M.Pharm.-Syllabus

SYLLABUS - M. PHARM COURSES w.e.f.
Session 2017-18
M. PHARM. PHARMACEUTICAL CHEMISTRY (MPC)
SEMESTER-1
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MPA101T)
Scope
This subject deals with various advanced analytical instrumental techniques for identification,
characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR, HPLC,
GC etc.
Objectives
After completion of course student is able to know,
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments
THEORY 60 HOURS
1 UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-Visible
spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible spectroscopy.
IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling, Instrumentation of
Dispersive and Fourier – Transform IR Spectrometer, Factors affecting vibrational frequencies and
Applications of IR spectroscopy
Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence, Quenchers, Instrumentation
and Applications of fluorescence spectrophotometer.
Flame emission spectroscopy and Atomic absorption spectroscopy: Principle, Instrumentation,
Interferences and Applications.
12 Hrs
2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent
requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors
influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy.
12 Hrs
3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types of
ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic peaks and
Applications of Mass spectroscopy
12 Hrs
4 Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting
resolution and applications of the following: a) Paper chromatography b) Thin Layer chromatography c)
Ion exchange chromatography d) Column chromatography e) Gas chromatography f) High Performance
Liquid chromatography g) Affinity chromatography
12 Hrs
5 Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation and
applications of the following: a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis
d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing
X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s law, Rotating crystal
technique, X ray powder technique, Types of crystals and applications of X-ray diffraction.
12 Hrs
REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition, John Wiley
& Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th
edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS Publishers, New
Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS
Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel Dekker Series
ADVANCED ORGANIC CHEMISTRY-1 (MPC101T)

Scope
The subject is designed to provide in-depth knowledge about advances in organic chemistry, different
techniques of organic synthesis and their applications to process chemistry as well as drug discovery.
Objectives
Upon completion of course, the student shall be to understand-
 The principles and applications of retero-synthesis
 The mechanism & applications of various named reactions
 The concept of disconnection to develop synthetic routes for small target molecule.
 The various catalysts used in organic reactions
 The chemistry of heterocyclic compounds
THEORY 60 Hrs
1. Basic Aspects of Organic Chemistry
a. Organic intermediates: Carbocations, carbanions, free radicals, carbenes and nitrenes. Their method of
formation, stability and synthetic applications.
b. Types of reaction mechanisms and methods of determining them,
c. Detailed knowledge regarding the reactions, mechanisms and their relative reactivity and orientations.
i. Aliphatic and aromatic compounds,
ii. Nucleophilic uni- and bimolecular reactions (SN1 and SN2)
iii. Elimination reactions (E1 & E2; Hoffman & Saytzeff’s rule)
iv. Rearrangement reaction
12Hrs
2. Study of mechanism synthetic applications of following named Reactions:
Ugi reaction, Brook rearrangement, Ullmann coupling reactions, Dieckmann Reaction, Doebner-Miller
Reaction, Sandmeyer Reaction, Mitsunobu reaction, Mannich reaction, Vilsmeyer-Haack Reaction,
Sharpless asymmetric epoxidation, Baeyer-Villiger oxidation, Shapiro & Suzuki reaction, Ozonolysis and
Michael addition reaction
12 Hrs
3. Synthetic Reagents & Applications
Aluminiumisopropoxide, N-bromosuccinamide, diazomethane, dicyclohexylcarbodimide, Wilkinson
reagent, Witting reagent. Osmium tetroxide, titanium chloride, diazopropane, diethyl azodicarboxylate,
Triphenylphosphine, Benzotriazol-1-yloxy) tris (dimethylamino) phosphonium hexafluoro-phosphate
(BOP).
Protecting groups
a. Role of protection in organic synthesis
b. Protection for the hydroxyl group, including 1,2-and1,3-diols: ethers, esters, carbonates, cyclic acetals
& ketals
c. Protection for the Carbonyl Group: Acetals and Ketals
d. Protection for the Carboxyl Group: amides and hydrazides, esters
e. Protection for the Amino Group and Amino acids: carbamates and amides
12Hrs
4. Heterocyclic Chemistry
General methods of synthesis and applications of drugs of five, six membered and fused heterocylces
such as imidazole, pyrazole, triazole, pyrimidine, quinoline, acridine, phenothiazine and purine. Synthesis
of few representative drugs containing these heterocyclic nucleus
12Hrs
5. Synthon approach and retrosynthesis applications
i. Basic principles, terminologies and advantages of retrosynthesis; guidelines for dissection of molecules.
Functional group interconvertion and addition (FGI and FGA)
ii. C‐X disconnections; C‐C disconnections – alcohols and carbonyl compounds; 1,2‐, 1,3‐,1,4‐, 1,5‐, 1,6‐
difunctionalized compounds
iii. Strategies for synthesis of three, four, five and six‐membered ring
12Hrs
REFERENCES
1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J March, John Wiley and sons,
New York.
2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart and Winston, NewYork.
3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford University Press 2001.
4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995.
5. A guide to mechanisms in Organic Chemistry – Peter Skyes (Orient Longman, New Delhi).
6. Reactive intermediates in organic chemistry – Tandom and Gowel. 60
7. Combinational Chemistry – Synthesis and applications – Stephen R Wilson & Anthony W Czarnik.
8. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.)
9. Organic synthesis-The disconnection approach, S. Warren, Wily India
10. Principles of organic synthesis, ROC Norman and JM Coxan, Nelson thorns
11. Organic synthesis- Special techniques VK Ahluwalia and R Agarwal, Narosa Publishers
12. Organic reaction mechanisms IV edtn, VK Ahluwalia and RK Parashar, Narosa Publishers
ADVANCED MEDICINAL CHEMISTRY (MPC102T)

Scope
The subject is designed to impart knowledge about recent advances in the field of medicinal chemistry at
the molecular level including different techniques for the rational drug design.
Objectives
At completion of this course it is expected that students will be able to understand-
 Different stages of drug discovery
 Role of medicinal chemistry in drug research
 Different techniques for drug discovery
 Various strategies to design and develop new drug like molecules for biological targets
 Peptidomimetics
THEORY 60 Hrs
1. Drug discovery: Stages of drug discovery, lead discovery; identification, validation and diversity of
drug targets. Chemistry of prostaglandins, leukotrienes and thromboxones.
Biological drug targets: Receptors, types, binding and activation, theories of drug receptor interaction,
drug receptor interactions, agonists vs antagonists, artificial enzymes.
12 Hrs
2. Prodrug Design and Analog design:
 Prodrug design: Basic concept, Carrier linked prodrugs/ Bioprecursors, Prodrugs of functional group,
Prodrugs to improve patient acceptability, Drug solubility, Drug absorption and distribution, site specific
drug delivery and sustained drug action. Rationale of prodrug design and practical consideration of
prodrug design.
 Combating drug resistance: Causes for drug resistance, strategies to combat drug resistance in
antibiotics and anticancer therapy, Genetic principles of drug resistance.
 Analog Design: Introduction, Classical & Non classical, Bioisosteric replacement strategies, rigid
analogs, alteration of chain branching, changes in ring size, ring position isomers, design of stereo
isomers and geometric isomers, fragments of a lead molecule, variation in inter atomic distance.
12Hrs
3 Chemistry of Synthetic drugs: Systematic study, SAR, Mechanism of action and synthesis of new
generation molecules of following class of drugs: Anti-hypertensive drugs, Psychoactive drugs,
Anticonvulsant drugs, H1 & H2 receptor antagonist, COX1 & COX2 inhibitors, Adrenergic &
Cholinergic agents, Antineoplastic and Antiviral agents.
Stereochemistry and Drug action: Realization that stereo selectivity is a pre-requisite for evolution.
Role of chirality in selective and specific therapeutic agents. Case studies, Enantio selectivity in drug
adsorption, metabolism, distribution and elimination.
12 Hrs
4. Rational Design of Enzyme Inhibitors: Enzyme kinetics & Principles of Enzyme inhibitors,Enzyme
inhibitors in medicine, Enzyme inhibitors in basic research, rational design of non-covalently and
covalently binding enzyme inhibitors.
12 Hrs
5. Peptidomimetics: Therapeutic values of Peptidomimetics, design of peptidomimetics by manipulation
of the amino acids, modification of the peptide backbone, incorporating conformational constraints
locally or globally.
Combinatorial chemistry and High throughput screening: Different techniques, Solid phase synthesis,
Solution phase synthesis, Parallel synthesis, applications of combinatorial chemistry. High Throughput
Screening- general outline, importance and application.
12 Hrs
REFERENCES:
1. Medicinal Chemistry by Burger.
2. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical Chemistry.
3. Comprehensive Medicinal Chemistry – Corwin and Hansch.
4. Computational and structural approaches to drug design edited by Robert M Stroud and Janet. F Moore
5. Introduction to Quantitative Drug Design by Y.C. Martin.
6. Principles of Medicinal Chemistry by William Foye.
7. Drug Design Volumes by Arienes.
8. Principles of Drug Design by Smith.
9. The Organic Chemistry of the Drug Design and Drug action by Richard B.Silverman.
10. An Introduction to Medicinal Chemistry –Graham L.Patrick, (III Edition.)
11. Biopharmaceutics and pharmacokinetics by DM.Brahmankar, Sunil B .Jaiswal.
12. Peptidomimetics in Organic and Medicinal Chemistry by Antonio Guarna and Andrea Trabocchi,
First edition, Wiley publishers.
CHEMISTRY OF NATURAL PRODUCTS (MPC103T)
Scope
The subject is designed to provide detail knowledge about chemistry of medicinal compounds from
natural origin and general methods of structural elucidation of such compounds. It also emphasizes on
isolation, purification and characterization of medicinal compounds from natural origin.
Objectives
 Different types of natural compounds and their chemistry and medicinal importance
 The importance of natural compounds as lead molecules for new drug discovery
 The concept of rDNA technology tool for new drug discovery
 General methods of structural elucidation of compounds of natural origin
 Isolation, purification and characterization of simple chemical constituents from natural source
THEORY 60 Hrs
1. Study of Natural products as leads for new pharmaceuticals for the following class of drugs:
a. Drugs Affecting the Central Nervous System: Morphine Alkaloids
b. Anticancer Drugs: Paclitaxel and Docetaxel, Etoposide, and Teniposide
c. Cardiovascular Drugs: Lovastatin, Teprotide and Dicoumarol
d. Neuromuscular Blocking Drugs: Curare alkaloids
e. Chemistry of macrolid antibiotics: Erythromycine, Azithromycine, Cephalosporins(New generation)
12Hrs
2. Alkaloids- General introduction, classification, isolation, purification, stereochemistry, molecular
modification and biological activity of alkaloids, general methods of structural determination of alkaloids,
structural elucidation of ephedrine, morphine, ergot, emetine and reserpine.
Flavonoids. Introduction, isolation and purification of flavonoids, General methods of structural
determination of flavonoids; Structural elucidation of quercetin.
12Hrs
3. Steroids- General introduction, chemistry of sterols, sapogenin and cardiac glycosides.
Stereochemistry and nomenclature of steroids, Structure elucidation of male & female sex
hormones( testosterone, Estradial, progesterone), Adrenocortcoids (carsisone) and contraceptive agents.
Terpenoids – Classification, isolation, isoprene rule and general methods of structural elucidation of
Terpenoids; Structural elucidation of drugs belonging to mono, di and tri terpenoids, carotinoids.
12Hrs
4. Recombinant DNA technology and drug discovery:
rDNA technology, hybridoma technology, New pharmaceuticals derived from biotechnology;
Oligonucleotide therapy. Gene therapy: Introduction, Clinical application and recent advances in gene
therapy, principles of RNA & DNA estimation
Active constituent of certain crude drugs used in Indigenous system.
Diabetic therapy – Gymnema sylvestre, Salacia reticulate, Pterocarpus marsupiam, Swertia chirata,
Trigonella foenum graccum; Liver dysfunction – Phyllanthus niruri; Antitumor – Curcuma longa Linn.
12Hrs
5. Structural Characterization of natural Products
Structural characterization of natural compounds using IR, 1HNMR, 13CNMR and MS Spectroscopy
12Hrs
REFERENCES
1. Modern methods of plant analysis – Peech and M.V.Tracey.
2. Phytochemistry Vol. I and II by Miller, Jan Nostrant Rein Hld.
3. Recent advances in Phytochemistry Vol. I to IV – Scikel Runeckles.
4. Chemistry of natural products Vol I onwards IWPAC.
5. Natural Product Chemistry Nakanishi Gggolo.
6. Natural Product Chemistry “A laboratory guide” – Rapheal Khan.
7. The Alkaloid Chemistry and Physiology by THF Manske.
8. Introduction to molecular Phytochemistry – CHJ Wells, Chapmannstall.
9. Organic Chemistry of Natural Products Vol I and II by Gurdeep and Chatwall.
10. Organic Chemistry of Natural Products Vol I and II by O.P. Agarwal.
11. Organic Chemistry Vol I and II by I.L. Finar
12. Elements of Biotechnology by P.K. Gupta.
13. Pharmaceutical Biotechnology by S.P.Vyas and V.K.Dixit.
14. Biotechnology by Purohit and Mathoor.
15. Phytochemical methods of Harborne.
16. Burger’s Medicinal Chemistry.
PHARMACEUTICAL CHEMISTRY PRACTICAL-I (MPC104P)
1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer, RNA &
DNA estimation
2. Simultaneous estimation of multi component containing formulations by UV spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry
To perform the following reactions of synthetic importance
7. Purification of organic solvents, column chromatography
8. Claisen-schimidt reaction.
9. Benzyllic acid rearrangement.
10. Beckmann rearrangement.
11. Hoffmann rearrangement
12. Mannich reaction
13. Synthesis of medicinally important compounds involving more than one step along with purification
and Characterization using TLC, melting point and IR spectroscopy (4 experiments)
14. Estimation of elements and functional groups in organic natural compounds
15. Isolation, characterization like melting point, mixed melting point, molecular weight determination,
functional group analysis, co-chromatographic technique for identification of isolated compounds and
interpretation of UV and IR data.
16. Some typical degradation reactions to be carried on selected plant constituents
SEMESTER-II
ADVANCED SPECTRAL ANALYSIS (MPC201T)

Scope
This subject deals with various hyphenated analytical instrumental techniques for identification,
characterization and quantification of drugs. Instruments dealt are LC-MS, GC-MS, ATR-IR, DSC etc.
Objectives
 Interpretation of the NMR, Mass and IR spectra of various organic compounds
 Theoretical and practical skills of the hyphenated instruments
 Identification of organic compounds
THEORY 60Hrs
1. UV and IR spectroscopy: Wood ward – Fiesure rule for 1,3- butadienes, cyclic dienes and α, β-
carbonyl compounds and interpretation compounds of enones. ATR-IR, IR Interpretation of organic
compounds.
12Hrs
2. NMR spectroscopy: 1-D and 2-D NMR, NOESY and COSY, HECTOR, INADEQUATE techniques,
Interpretation of organic compounds.
12Hrs
3. Mass Spectroscopy: Mass fragmentation and its rules, Fragmentation of important functional groups
like alcohols, amines, carbonyl groups and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring
rule, Isotopic peaks, Interpretation of organic compounds.
12Hrs
4. Chromatography: Principle, Instrumentation and Applications of the following:
a) GC-MS b) GC-AAS c) LC-MS d) LC-FTIR e) LC-NMR f) CE-MS g) High Performance Thin Layer
chromatography h) Super critical fluid chromatography i) Ion Chromatography j) I-EC (Ion-Exclusion
Chromatography) k) Flash chromatography.
12Hrs
5. Thermal methods of analysis – Introduction, principle, instrumentation and application of DSC, DTA
and TGA.
Raman Spectroscopy: Introduction, Principle, Instrumentation and Applications.
Radio immuno assay: Biological standardization , bioassay, ELISA, Radioimmuno assay of digitalis and
insulin
12Hrs
REFERENCES
& Sons, 2004.
5. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D Sethi, CBS Publishers, New
Delhi.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3 rd Edition, CBS Publishers,
New Delhi, 1997.
ADVANCED ORGANIC CHEMISTRY–II (MPC202T)

Scope
The subject is designed to provide in-depth knowledge about advances in organic chemistry, different
techniques of organic synthesis and their applications to process chemistry as well as drug discovery.
Objectives
Upon completion of course, the student shall able to understand
 The principles and applications of Green chemistry
 The concept of peptide chemistry.
 The various catalysts used in organic reactions
 The concept of stereochemistry and asymmetric synthesis.
THEORY 60 Hrs
1. Green Chemistry
a. Introduction, principles of green chemistry
b. Microwave assisted reactions: Merit and demerits of its use, increased reaction rates, mechanism,
superheating effects of microwave, effects of solvents in microwave assisted synthesis, microwave
technology in process optimization, its applications in various organic reactions and heterocycles
synthesis
c. Ultrasound assisted reactions: Types of sonochemical reactions, homogenous, heterogeneous liquid-
liquid and liquid-solid reactions, synthetic applications
d. Continuous flow reactors: Working principle, advantages and synthetic applications.
12Hrs
2. Chemistry of peptides
a. Coupling reactions in peptide synthesis
b. Principles of solid phase peptide synthesis, t-BOC and FMOC protocols, various solid supports and
linkers: Activation procedures, peptide bond formation, deprotection and cleavage from resin, low and
high HF cleavage protocols, formation of free peptides and peptide amides, purification and case studies,
site-specific chemical modifications of peptides
c. Segment and sequential strategies for solution phase peptide synthesis with any two case studies
d. Side reactions in peptide synthesis: Deletion peptides, side reactions initiated by proton abstraction,
protonation, over-activation and side reactions of individual amino acids.
12Hrs
3. Photochemical Reactions
Basic principles of photochemical reactions. Photo-oxidation, photo-addition and photo-fragmentation
Pericyclic reactions
Mechanism, Types of pericyclic reactions such as cyclo addition, elctrocyclic reaction and sigmatrophic
rearrangement reactions with examples
12Hrs
4. Catalysis
a. Types of catalysis, heterogeneous and homogenous catalysis, advantages and disadvantages
b. Heterogeneous catalysis – preparation, characterization, kinetics, supported catalysts, catalyst
deactivation and regeneration, some examples of heterogeneous catalysis used in synthesis of drugs.
c. Homogenous catalysis, hydrogenation, hydroformylation, hydrocyanation, Wilkinson catalysts, chiral
ligands and chiral induction, Ziegler‐Natta catalysts, some examples of homogenous catalysis used in
synthesis of drugs
d. Transition-metal and Organo-catalysis in organic synthesis: Metal-catalyzed reactions
e. Biocatalysis: Use of enzymes in organic synthesis, immobilized enzymes/cells in organic reaction.
f. Phase transfer catalysis ‐ theory and applications
12Hrs
5. Stereochemistry & Asymmetric Synthesis
a. Basic concepts in stereochemistry – optical activity, specific rotation racemates and resolution of
racemates, the Cahn, Ingold, Prelog (CIP) sequence rule, meso compounds, pseudo asymmetric centres,
axes of symmetry, Fischers D and L notation, cis-trans isomerism, E and Z notation.
b. Methods of asymmetric synthesis using chiral pool, chiral auxiliaries and catalytic asymmetric
synthesis, enantiopure separation and Stereo selective synthesis with examples.
12Hrs
REFERENCES
1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J March, John Wiley and sons,
New York.
2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart and Winston, NewYork.
3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford University Press 2001.
4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995.
5. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.)
6. Organic synthesis-the disconnection approach, S. Warren, Wily India
7. Principles of organic synthesis, ROCNorman and JMCoxan, Nelson thorns
8. Organic synthesis- Special techniques VK Ahluwalia and R Aggarwal, Narosa Publishers
9. Organic reaction mechanisms IV edtn, VK Ahluwalia and RK Parashar, Narosa Publishers
COMPUTER AIDED DRUG DESIGN (MPC203T)

Scope
The subject is designed to impart knowledge on the current state of the art techniques involved in
computer assisted drug design.
Objectives
 Role of CADD in drug discovery
 Different CADD techniques and their applications
 Various strategies to design and develop new drug like molecules.
 Working with molecular modeling softwares to design new drug molecules
 The in silico virtual screening protocols
Theory 60 Hrs
1. Introduction to Computer Aided Drug Design (CADD): History, different techniques and
applications.
Quantitative Structure Activity Relationships: Basics
History and development of QSAR: Physicochemical parameters and methods to calculate
physicochemical parameters: Hammett equation and electronic parameters (sigma), lipophilicity effects
and parameters (log P, pi-substituent constant), steric effects (Taft steric and MR parameters)
Experimental and theoretical approaches for the determination of these physicochemical parameters.
12 Hrs
2. Quantitative Structure Activity Relationships: Applications
Hansch analysis, Free Wilson analysis and relationship between them, Advantages and disadvantages;
Deriving 2D-QSAR equations. 3D-QSAR approaches and contour map analysis.
Statistical methods used in QSAR analysis and importance of statistical parameters.
12 Hrs
3. Molecular Modeling and Docking
a. Molecular and Quantum Mechanics in drug design
b. Energy Minimization Methods: comparison between global minimum conformation and bioactive
conformation Molecular docking and drug receptor interactions: Rigid docking, flexible docking and
extra-precision docking. Agents acting on enzymes such as DHFR, HMG-CoA reductase and HIV
protease, choline esterase ( AchE & BchE)
12 Hrs
4. Molecular Properties and Drug Design
a. Prediction and analysis of ADMET properties of new molecules and its importance in drug design.
b. De novo drug design: Receptor/enzyme-interaction and its analysis, Receptor/enzyme cavity size
prediction, predicting the functional components of cavities, Fragment based drug design.
c. Homology modeling and generation of 3D-structure of protein.
12 Hrs
5. Pharmacophore Mapping and Virtual Screening Concept of pharmacophore, pharmacophore
mapping, identification of Pharmacophore features and Pharmacophore modeling; Conformational search
used in pharmacophore mapping. In Silico Drug Design and Virtual Screening Techniques Similarity
based methods and Pharmacophore based screening, structure based in silico virtual screening protocols.
12 Hrs
REFERENCES:
1. Computational and structural approaches to drug design edited by Robert M Stroud and Janet. F Moore
2. Introduction to Quantitative Drug Design by Y.C. Martin.
3. Drug Design by Ariens Volume 1 to 10, Academic Press, 1975.
4. Principles of Drug Design by Smith and Williams.
5. The Organic Chemistry of the Drug Design and Drug action by Richard B. Silverman.
6. Medicinal Chemistry by Burger.
7. An Introduction to Medicinal Chemistry –Graham L. Patrick, (III Edition.)
8. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical Chemistry.
9. Comprehensive Medicinal Chemistry – Corwin and Hansch.
10. Computational and structural approaches to drug design edited by Robert M Stroud and Janet. F
Moore
PHARMACEUTICAL PROCESS CHEMISTRY (MPC204T)
Scope
Process chemistry is often described as scale up reactions, taking them from small quantities created in
the research lab to the larger quantities that are needed for further testing and then to even larger
quantities required for commercial production. The goal of a process chemist is to develop synthetic
routes that are safe, cost-effective, environmentally friendly, and efficient. The subject is designed to
impart knowledge on the development and optimization of a synthetic route/s and the pilot plant
procedure for the manufacture of Active Pharmaceutical Ingredients (APIs) and new chemical entities
(NCEs) for the drug development phase.
Objectives
 The strategies of scale up process of apis and intermediates
 The various unit operations and various reactions in process chemistry
THEORY 60 Hrs
1. Process chemistry
a. Introduction, Synthetic strategy
b. Stages of scale up process: Bench, pilot and large scale process.
c. In-process control and validation of large scale process.
d. Case studies of some scale up process of APIs.
e. Impurities in API, types and their sources including genotoxic impurities
12 Hrs
2. Unit operations
a. Extraction: Liquid equilibria, extraction with reflux, extraction with agitation, counter current
extraction.
b. Filtration: Theory of filtration, pressure and vacuum filtration, centrifugal filtration,
c. Distillation: azeotropic and steam distillation
d. Evaporation: Types of evaporators, factors affecting evaporation.
e. Crystallization: Crystallization from aqueous, non-aqueous solutions factors affecting crystallization,
nucleation. Principle and general methods of Preparation of polymorphs, hydrates, solvates and
amorphous APIs.
12 Hrs
3. Unit Processes
a. Nitration: Nitrating agents, Aromatic nitration, kinetics and mechanism of aromatic nitration, process
equipment for technical nitration, mixed acid for nitration,
b. Halogenation: Kinetics of halogenations, types of halogenations, catalytic halogenations. Case study
on industrial halogenation process.
c. Oxidation: Introduction, types of oxidative reactions, Liquid phase oxidation with oxidizing agents.
Nonmetallic Oxidizing agents such as H2O2, sodium hypochlorite, Oxygen gas, ozonolysis.
12 Hrs
4. Unit Processes
a. Reduction: Catalytic hydrogenation, Heterogeneous and homogeneous catalyst; Hydrogen transfer
reactions, Metal hydrides. Case study on industrial reduction process.
b. Fermentation: Aerobic and anaerobic fermentation. Production of
i. Antibiotics; Penicillin and Streptomycin,
ii. Vitamins: B2 and B12
iii. Statins: lovastatin, simvastatin
Reaction progress kinetic analysis
a. Streamlining reaction steps, route selection,
b. Characteristics of expedient routes, characteristics of cost-effective routes, reagent selection, families
of reagents useful for scale-up.
12 Hrs
5. Industrial Safety
a. MSDS (Material Safety Data Sheet), hazard labels of chemicals and Personal Protection Equipment
(PPE)
b. Fire hazards, types of fire & fire extinguishers
c. Occupational Health & Safety Assessment Series 1800 (OHSAS-1800) and ISO-14001(Environmental
Management System), Effluents and its management
12 Hrs
REFERENCES:
1. Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever- Changing Climate-An
Overview; K. Gadamasetti
2. Pharmaceutical Manufacturing Encyclopedia, 3rd edition, Volume 2.
3. Medicinal Chemistry by Burger, 6th edition, Volume 1-8.
4. W.L. McCabe, J.C Smith, Peter Harriott. Unit operations of chemical engineering, 7th edition,
McGraw Hill
5. Polymorphism in Pharmaceutical Solids .Dekker Series Volume 95 Ed: H G Brittain (1999)
6. Regina M. Murphy: Introduction to Chemical Processes: Principles, Analysis, Synthesis
7. Peter J. Harrington: Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-
Up
8. P.H.Groggins: Unit processes in organic synthesis (MGH)
9. F.A.Henglein: Chemical Technology (Pergamon)
10. M.Gopal: Dryden’s Outlines of Chemical Technology
11. Clausen,Mattson: Principle of Industrial Chemistry
12. Lowenheim & M.K. Moran: Industrial Chemicals
13. S.D. Shukla & G.N. Pandey: A text book of Chemical Technology Vol. II
14. J.K. Stille: Industrial Organic Chemistry (PH)
15. Srreve: Chemical Procress
16. B.K.Sharma: Industrial Chemistry
17. ICH Guidelines
18. United States Food and Drug Administration official website www.fda.gov
PHARMACEUTICAL CHEMISTRY PRACTICAL-II (MPC205P)
1. Synthesis of organic compounds by adapting different approaches involving (3 experiments)

a. Oxidation
b. Reduction/hydrogenation
c. Nitration
2. Comparative study of synthesis of APIs/intermediates by different synthetic routes
(2 experiments)
3. Assignments on regulatory requirements in API (2 experiments)
4. Comparison of absorption spectra by UV and Wood ward – Fiesure rule
5. Interpretation of organic compounds by FT-IR
6. Interpretation of organic compounds by NMR
7. Interpretation of organic compounds by MS
8. Determination of purity by DSC in pharmaceuticals
9. Identification of organic compounds using FT-IR, NMR, CNMR and Mass spectra
10. To carry out the preparation of following organic compounds
11. Preparation of 4-chlorobenzhydrylpiperazine. (an intermediate for cetirizine HCl).
12. Preparation of 4-iodotolene from p-toluidine.
13. NaBH4 reduction of vanillin to vanillyl alcohol
14. Preparation of umbelliferone by Pechhman reaction
15. Preparation of triphenyl imidazole
16. To perform the Microwave irradiated reactions of synthetic importance (Any two)
17. Determination of log P, MR, hydrogen bond donors and acceptors of selected drugs using softwares
18. Calculation of ADMET properties of drug molecules and its analysis using softwares Pharmacophore
modeling
19. 2D-QSAR based experiments
20. 3D-QSAR based experiments
21. Docking study
22. Virtual screening based experiment
M. PHARM. PHARMACOGNOSY (MPG)
SEMESTER-I

Scope
characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR, HPLC,
GC etc.
Objectives
THEORY 60 HOURS
1 UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-Visible
spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible spectroscopy.
Dispersive and Fourier – Transform IR Spectrometer, Factors affecting vibrational frequencies and
Applications of IR spectroscopy
Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence, Quenchers, Instrumentation
and Applications of fluorescence spectrophotometer.
Flame emission spectroscopy and Atomic absorption spectroscopy: Principle, Instrumentation,
Interferences and Applications.
12 Hrs
2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent
requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors
influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy.
12 Hrs
3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types of
ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic peaks and
Applications of Mass spectroscopy
12 Hrs
4 Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting
resolution and applications of the following: a) Paper chromatography b) Thin Layer chromatography c)
Ion exchange chromatography d) Column chromatography e) Gas chromatography f) High Performance
Liquid chromatography g) Affinity chromatography
12 Hrs
5 Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation and
applications of the following: a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis
d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing
X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s law, Rotating crystal
technique, X ray powder technique, Types of crystals and applications of X-ray diffraction.
12 Hrs
REFERENCES
& Sons, 2004.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS Publishers, New
Delhi, 1997.
ADVANCED PHARMACOGNOSY-1 (MPG101T)

SCOPE:
To learn and understand the advances in the field of cultivation and isolation of drugs of natural
origin, various phytopharmaceuticals, nutraceuticals and their medicinal use and health benefits.
OBJECTIVES:
Upon completion of the course, the student shall be able to
1. Know the advances in the cultivation and production of drugs
2. Know the various phyto-pharmaceuticals and their source & utilization and medicinal value.
3. Know the various nutraceuticals/herbs and their health benefits
Course Description
THEORY 60 Hours
1. Plant drug cultivation: General introduction to the importance of Pharmacognosy in herbal
drug industry, Indian Council of Agricultural Research, Current good agricultural practices,
Current good cultivation practices, Current good collection practices, Conservation of medicinal
plants- Ex-situ and In-situ conservation of medicinal plants.
12 Hrs
2. Marine natural products: General methods of isolation and purification, Study of Marine
toxins, Recent advances in research in marine drugs, Problems faced in research on marine drugs
such as taxonomical identification, chemical screening and their solution.
12 Hrs
3. Nutraceuticals: Current trends and future scope, Inorganic mineral supplements, Vitamin
supplements, Digestive enzymes, Dietary fibres, Cereals and grains, Health drinks from natural
origin, Antioxidants, Polyunsaturated fatty acids, Herbs as functional foods, Formulation and
standardization of neutraceuticals, Regulatory aspects, FSSAI guidelines, Sources, name of
marker compounds and their chemical nature, medicinal uses and health benefits of following i)
Spirulina ii) Soya bean iii) Ginseng iv) Garlic v) Broccoli vi) Green and Herbal Tea vii) Flax
seeds viii) Black cohosh ix) Turmeric.
12 Hrs
4. Phytopharmaceuticals: Occurrence, isolation and characteristic features (Chemical nature,
uses in pharmacy, medicinal and health benefits) of following.
a) Carotenoids – i) α and β - Carotene ii) Xanthophyll (Lutein) b) Limonoids – i) d-Limonene ii)
α – Terpineol c) Saponins – i) Shatavarins d) Flavonoids – i) Resveratrol ii) Rutin iii) Hesperidin
iv) Naringin v) Quercetin e) Phenolic acids- Ellagic acid f) Tocotrienols and Tocopherols g)
Andrographolide, glycolipids, gugulipids, withanolides, vascine, taxol
12 Hrs
5. Pharmacovigilance of drugs of natural origin: WHO and AYUSH guidelines for safety
monitoring of natural medicine, Spontaneous reporting schemes for biodrug adverse reactions,
bio drug-drug and bio drug-food interactions with suitable examples.
12 Hrs
REFERENCES:
1) Cultivation of medicinal and aromatic crops, 1st edition, by AA Farooqui and B.S. Sreeramu.
University Press, 2001.
2) Medicinal natural products (a biosynthetic approach), 1st edition, by Paul M. Dewick, John
Wiley & Sons Ltd., England, 1998.
3) Natural Products from Plants, 1st edition, by Peter B. Kaufman, CRC Press, New York, 1998
4) Glimpses of Indian Ethano Pharmacology by P. Pushpangadam. Ulf Nyman. V.George
Tropical Botanic Garden & Research Institute, 1995.
5) Natural products: A lab guide by Raphael Ikan , 2nd Edition, Academic Press 1991.
6) Pharmacognosy - G. E. Trease and W.C. Evans. 15th Edition W.B. Saunders Edinburgh, New
York.
7) Pharmacognosy-Tyler, Brady, Robbers
8) Modem Methods of Plant Analysis- Peach & M.V. Tracey, Vol. I&II
9) Recent Advances in Phytochemistry- Vol. 1&4: Scikel Runeckles- Appleton Century crofts.
10) Chemistry of Marine Natural Products- Paul J. Schewer 1973.
11) Marine Natural Products-Vol.I to IV.
12) Cultivation of Medicinal Plants by C.K. Atal & B.M. Kapoor.
13) Cultivation and Utilization of Aromatic Plants By C.K. Atal & B.M. Kapoor
14) Herbal Drug Industry by RD. Choudhary, 1st edition, Eastern Publisher, New Delhi, 1996.
15) Text book of Pharmacognosy by C.K.Kokate, Purohit, Ghokhale, 4th edition, Nirali
Prakasshan, 1996.
16) Pharmacognosy and Pharmacobiotechnology by Ashutoshkar, New Age Publications, New
Delhi.
17) Text Book of Pharmacognosy by T.E. Wallis
PHYTOCHEMISTRY (MPG102T)
Scope:
Students shall be equipped with the knowledge of natural product drug discovery and will be
able to isolate, identify the extract and phyto-constituents
Objectives:
1. know the different classes of phytoconstituents and their properties and general process of
natural product drug discovery
2. know the process isolation, purification and identification of phytoconstituents
THEORY 60 Hrs
1. Biosynthetic pathways and Radio tracing techniques: Constituents & their Biosynthesis,
Isolation, Characterization and purification with a special reference to their importance in herbal
industries of following phyto-pharmaceuticals containing drugs:
a) Alkaloids: Ephedrine, Quinine, Strychynine, Piperine, Berberine, Taxol, Vincaalkoloids.
b) Glycosides: Digitoxin, Glycyrrhizin, Sennosides, Bacosides, Ginsenosides, Quercitin, Rutin.
c) Steroids: Hecogenin, guggulosterone and withanolides
d) Coumarin: Umbelliferone.
e) Terpenoids: Cucurbitacins
f) Carotenoids: Lycopene, β-carotene.
g) Camphor, Menthol, Eugenol.
12 Hrs
2. Drug discovery and development: History of herbs as source of drugs and drug discovery,
the lead structure selection process, structure development, product discovery process and drug
registration, Selection and optimization of lead compounds with suitable examples from
anticancer, CNS cardiovascular drugs, antitubercular drugs and immunomodulators, Clinical
studies emphasis on phase of clinical trials, protocol design for lead molecules.
12 Hrs
3. Extraction and Phytochemical studies: Recent advances in extractions with emphasis on
selection of method and choice of solvent for extraction, successive and exhaustive extraction
and other methods of extraction commonly used like microwave assisted extraction, and method
of fractionation. Detection of different classes of phytoconstituents by latest CCCET, SCFE
techniques including preparative HPLC and Flash column chromatography, AAS.
12 Hrs
4. Phytochemical finger printing: HPTLC and LCMS/GCMS characterization of extracts
containing alkaloids, saponins, glycosides and flavanoids.
12 Hrs
5. Pharmacological screening: In vitro, In vivo screening techniques with reference to
antiglycomerate, analgesics, antidiabetic, antilipidemic, anticancer, antiulcer, antiviral,
antipsychotic, antilithiatic, Toxicity studies as per OECD guidelines, acute, chronic and clinical
toxicity.
12 Hrs
REFERENCES:
1) Organic chemistry by I.L. Finar Vol.II
2) Pharmacognosy by Trease and Evans, ELBS.
3) Pharmacognosy by Tylor and Brady.
4) Text book of Pharmacognosy by Wallis.
5) Clark’s isolation and Identification of drugs by A.C. Mottal.
6) Plant Drug Analysis by Wagner & Bladt.
7) Wilson and Gisvolds text book of Organic Medicinnal and Pharmaceutical Chemistry by
Deorge. R.F.
8) The Chemistry of Natural Products, Edited by R.H. Thomson, Springer International
Edn. 1994.
9) Natural Products Chemistry Practical Manual by Anees A Siddiqui and SeemiSiddiqui
10) Organic Chemistry of Natural Products, Vol. 1&2. Gurdeep R Chatwal.
11) Chemistry of Natural Products- Vol. 1 onwards IWPAC.
12) Modem Methods of Plant Analysis- Peach & M.V. Tracey, Vol. I&II
INDUSTRIAL HERBAL DRUG TECHNOLOGY (MPG103T)

Scope:
To understand the Industrial and commercial potential of herbal drugs and drugs of natural
origin, integrate traditional medicines and systems of India with modern medicine and also to
know regulatory and quality policy for the trade of herbals and drugs of natural origin.
Objective:
By the end of the course the student shall be able to:-
1. Know the requirements for setting up the herbal/natural drug industry.
2. To know and understand the guidelines for quality of herbal/natural medicines and regulatory
issues.
3. To know patenting/IPR of herbals/natural drugs and trade of raw and finished materials.
THEORY 60Hrs
1. Herbal drug industry: Infrastructure of herbal drug industry involved in production of
standardized extracts and various dosage forms. Current challenges in upgrading and
modernization of herbal formulations. Entrepreneurship Development, Project selection, project
report, technical knowledge, Capital venture, plant design, layout and construction. Pilot plant
scale –up techniques, case studies of herbal extracts. Formulation production management.
12 Hrs
2. Regulatory requirements for setting herbal drug industry: Global marketing management.
Indian and international patent law as applicable herbal drugs and natural products. Export –
import (EXIM) policy, TRIPS, IPR. Quality assurance in herbal/natural drug products. Concepts
of TDM, GMP, GLP, ISO-9000.
12Hrs
3. Monographs of herbal drugs: Study of monographs of herbal drugs and comparative study
in IP, USP, Ayurvedic pharmacopoeia, American herbal pharmacopoeia, British herbal
pharmacopoeia, Siddha and Unani Pharmacopoeia, WHO guidelines in quality assessment of
herbal drugs.
12 Hrs
4. Testing of natural products and drugs: Effect of herbal medicines on clinical laboratory
testing. Regulation and dispensing of herbal drugs. Stability testing of natural products,
protocols.
12 Hrs
5. Patents: Indian and international patent laws, proposed amendments as applicable to
herbal/natural products and process. Geographical indication, Copyright, Patentable subject
maters, novelty, non obviousness, utility, enablement and best mode, procedure for Indian patent
filing, patent processing, grant of patents, rights of patents, cases of patents, opposition and
revocation of patents, patent search and literature, Controllers of patents.
12 Hrs
REFERENCES:
1. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.
2. GMP for Botanicals - Regulatory and Quality issues on Phytomedicine by Pulok K Mukharjee
(2003), Ist Edition, Business horizons Robert Verpoorte, New Delhi.
3. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.
4. The complete technology book on herbal perfumes and cosmetics, by H.Pande, National
Institute of Industrial Research, Delhi.
5. Quality control of herbal drugs by Pulok K Mukarjee (2002), Ist Edition, Business Horizons
Pharmaceutical Publisher, New Delhi.
6. PDR for Herbal Medicines (2000), 2nd Edition, Medicinal Economic Company, New Jersey.
7. Indian Herbal Pharmacopoeia (2002), Revised Edition, 1DMA, Mumbai.
8. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (1996), 4th Edition, Nirali
Prakashan, New Delhi.
9. Text book of Pharmacognosy and Phytochemistry by Vinod D. RangarI (2002), Part I & II,
Career Publication, Nasik, India.
10. Plant drug analysis by H.Wagner and S.Bladt, 2nd edition, Springer, Berlin.
11. Standardization of Botanicals. Testing and extraction methods of medicinal herbs by V.
Rajpal (2004), Vol.I, Eastern Publisher, New Delhi.
12. Phytochemical Dictionary. Handbook of Bioactive Compounds from Plants by J.B.Harborne,
(1999), IInd Edition, Taylor and Francis Ltd, UK.
13. Herbal Medicine. Expanded Commission E Monographs by M.Blumenthal, (2004), IST
Edition,
14. Drug Formulation Manual by D.P.S.Kohli and D.H.Shah (1998), II Edition, Eastern
Publisher, New Delhi.
PHARMACOGNOSY PRACTICAL-I (MPGI04P)
1. Analysis of pharmacopoeial compounds of natural origin and their formulations by UV Vis

spectrophotometer
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Analysis of recorded spectra of simple phytoconstituents
6. Developmernt of fingerprint of selected medicinal plant extracts commonly used in herbal
drug industry viz. ashwagandha, tulsi, bael, amla, ginger, aloe, vidang, senna, lawronia by
HPTLC method
7. Method of extraction
8. Phytochemical screening
9. Thin layer chromatography
10. Demonstration of HPLC- estimation of glycyeizin
11. Monograph analysis of clove oil
12. Monograph analysis of castor oil.
13. Identification of bioactive constituents from plant extracts
14. Formulation using qualitative and quantitative methods.
SEMESTER-II
MEDICINAL PLANT BIOTECHNOLOGY (MPG201T)

Scope
To explore the knowledge of Biotechnology and its application in the improvement of quality of
medicinal plants
Objectives
 Know the process like genetic engineering in medicinal plants for higher yield of
Phytopharmaceuticals.
 Use the biotechnological techniques for obtaining and improving the quality of natural
products/medicinal plants
THEORY 60Hrs
1. Introduction to Plant biotechnology: Historical perspectives, prospects for development of
plant biotechnology as a source of medicinal agents. Applications in pharmacy and allied fields.
Genetic and molecular biology as applied to pharmacognosy, study of DNA, RNA and protein
replication, genetic code, regulation of gene expression, structure and complicity of genome, cell
signaling, DNA recombinant technology.
12 Hrs
2. Different tissue culture techniques: Organogenesis and embryogenesis, synthetic seed and
monoclonal variation, Protoplast fusion, Hairy root multiple shoot cultures and their applications.
Micro propagation of medicinal and aromatic plants. Sterilization methods involved in tissue
culture, gene transfer in plants and their applications.
12 Hrs
3. Immobilisation techniques & Secondary Metabolite Production:
Immobilization techniques of plant cell and its application on secondary metabolite Production.
Cloning of plant cell: Different methods of cloning and its applications. Advantages and
disadvantages of plant cell cloning. Secondary metabolism in tissue cultures with emphasis on
production of medicinal agents. Precursors and elicitors on production of secondary metabolites.
12 Hrs
4. Biotransformation and Transgenesis:
Biotransformation, bioreactors for pilot and large scale cultures of plant cells and retention of
biosynthetic potential in cell culture. Transgenic plants, methods used in gene identification,
localization and sequencing of genes. Application of PCR in plant genome analysis.
12 Hrs
5. Fermentation technology:
Application of Fermentation technology, Production of ergot alkaloids, single cell proteins,
enzymes of pharmaceutical interest.
12 Hrs
REFERENCES:
1. Plant tissue culture – Bhagwani, Vol 5. ( Elsevier)
2. Plant cell and Tissue Culture ( Lab. Manual ) – J.R.M.M. Yeoman.
3. Elements in biotechnology by P. K. Gupta.
4. An introduction to plant tissue culture by M. K. Razdan.
5. Experiments in plant tissue culture by John H. D and Lorin W. R.
6. Pharmaceutical biotechnology by S. P. Vyas and V. K. Dixit.
7. Plant cell and tissue culture by Jeffrey W. Pollard and John M Walker.
8. Plant tissue culture by Dixon, Oxford Washington DC, 1985
9. Plant tissue culture by Street.
10. Pharmacognosy by G. E. Trease and W. C. Evans.
11. Biotechnology by Purohit and Mathur.
12. Biotechnological applications to tissue culture by Shargool.
13. Pharmacognosy by Virroo E. Tyler, Lynn R. Brady and James E. Robberrt.
ADVANCED PHARMACOGNOSY-II (MPG202T)

Scope:
To know and understand the Adulteration and Deterioration that occurs in herbal/natural drugs
and methods of detection of the same. Study of herbal remedies and their validations, including
methods of screening
Objectives
 Know the validation of herbal remedies
 Know the methods of detection of adulteration and evaluation techniques for the herbal drugs
 To know the methods of screening of herbals for various biological properties
THEORY 60Hrs
1. Herbal remedies – Toxicity and Regulations:
Herbals vs Conventional drugs, Efficacy of Herbal medicine products, Validation of herbal
therapies, Pharmacodynamic and Pharmacokinetic issues.
12 Hrs
2. Adulteration and Deterioration: Introduction, Types of Adulteration/ Substitution of Herbal
drugs, Causes and Measures of Adulteration, Sampling Procedures, Determination of Foreign
Matter, DNA Finger printing techniques in identification of drugs of natural origin, heavy
metals, pesticide residues, phytotoxin, microbial contamination in herbs fruital formulation.
12 Hrs
3. Ethnobotany and Ethnopharmacology: Ethnobotany in herbal drug evaluation, Impact of
Ethnobotany in traditional medicine, New development in herbals, Bioprospecting tools for drug
discovery, Role of Ethnopharmacology in drug evaluation, Reverse Pharmacology.
12 Hrs
4. Analytical Profiles of herbal drugs: Andrographis paniculata, Boswellia serata, Coleus
forskholii, Curcuma longa, Embelica officinalis, Psoralea corylifolia.
12 Hrs
5. Biological screening of herbal drugs: Introduction and Need for Phyto- Pharmacological
Screening, New Strategies for evaluating Natural Products, In vitro evaluation techniques for
Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques for Anti-
inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio
protective, Diuretics and Antifertility.
12 Hrs
REFERENCES:
1. Glimpses of Indian Ethano Pharmacology by P. Pushpangadam. Ulf Nyman. V. George
Tropical Botanic Garden & Research Institute, 1995.
2. Natural products: A lab guide by Raphael Ikan , 2nd Edition, Academic Press1991.
3. Pharmacognosy - G. E. Trease and W.C. Evans. 15th Edition W.B. Saunders Edinburgh, New
York.
4. Pharmacognosy-Tyler, Brady, Robbers
5. Modem Methods of Plant Analysis- Peach & M.V. Tracey, Vol. I&II
6. Herbal Drug Industry by RD. Choudhary, 1st edition, Eastern Publisher, New Delhi, 1996.
7. Text book of Pharmacognosy by C.K.Kokate, Purohit, Ghokhale, 4th edition, Nirali
Prakasshan, 1996.
8. Text Book of Pharmacognosy by T.E. Wallis
9. Quality control of herbal drugs by Pulok K Mukarjee (2002), Ist Edition, Business Horizons
Pharmaceutical Publisher, New Delhi.
11. Text book of Pharmacognosy and Phytochemistry by Vinod D. RangarI (2002), Part I & II,
Career Publication, Nasik, India.
12. Plant drug analysis by H.Wagner and S.Bladt, 2nd edition, Springer, Berlin.
13. Standardization of Botanicals. Testing and extraction methods of medicinal herbs by V.
Rajpal (2004), Vol.I, Eastern Publisher, New Delhi.
14. Herbal Medicine. Expanded Commission E Monographs by M.Blumenthal, (2004), IST
Edition.
INDIAN SYSTEMS OF MEDICINE (MPG203T)

Scope
To make the students understand thoroughly on principles, preparations of medicines of various
Indian systems of medicine like Ayurveda, Siddha, Homeopathy and Unani. Also focusing on
clinical research of traditional medicines, quality assurance and challenges in monitoring the
safety of herbal medicines.
Objective
After completion of the course, student is able to
 To understand the basic principles of various Indian systems of medicine
 To now the clinical research of traditional medicines, Current Good Manufacturing
Practice of Indian systems of medicine and formulation.
THEORY
60Hrs
1. Fundamental concepts of Ayurveda, Siddha, Unani, and Homoeopathy systems of
medicine:
Different dosage forms of the ISM Ayurveda: Chronological development of Charak Samhita,
Sushrut Samhita and Kashyapa Samhita. Ayurvedic Pharmacopoeia Analysis of Ayurvedic
Formulations and crude drugs with references to: Identity, purity and quality of crude drugs.
Siddha: Gunapadam (Siddha Pharmacology), raw drugs/Dhatu/Jeevam in siddha system of
medicine, Purification process (Suddhi).
12Hrs
2. Naturopathy, Yoga and Aromatherapy practices:
a) Naturopathy - Introduction, basic principles and treatment modalities.
b) Yoga - Introduction and Streams of Yoga. Asanas, Pranayama, Meditations and Relaxation
techniques.
c) Aromatherapy – Introduction, aroma oils for common problems, carrier oils.
12 Hrs
3.Formulation development of various systems of medicine: Salient features of the techniques
of preparation of some of the important class of Formulations as per Ayurveda, Siddha,
Homeopathy and Unani Pharmacopoeia and texts. Standardization, Shelf life and Stability
studies of ISM formulations.
12 Hrs
4. Schedule T – Good Manufacturing Practice of Indian systems of medicine:
Components of GMP (Schedule – T) and its objectives, Infrastructural requirements, working
space, storage area, machinery and equipments, standard operating procedures, health and
hygiene, documentation and records. Quality assurance in herbal drug industry of GAP, GMP
and GLP in traditional system of medicine. Preparation of documents for new drug application
and export registration. Challenges in monitoring the safety of herbal medicines: Regulation,
quality assurance and control, National/regional pharmacopoeias.
12 Hrs
5. TKDL, Geographical indication skill, Government skills in AYUSH, ISM, CCRAS, CCRS,
CCRH, CCRU.
12 Hrs
REFERENCES:
1. Ayurvedic Pharmacopoeia (2004), The Controller of Publications, Civil Lines, Govt. of
India, New Delhi.
2. Hand Book on Ayurvedic Medicines by H.Panda National Institute of Industrial Research,
New Delhi.
3. Ayurvedic System of Medicine by Kaviraj Nagendranath Sengupata (1998), 2nd Revised
Edition, Sri Satguru Publications, New Delhi.
4. Ayurvedic Pharmacopoeia. Formulary of Ayurvedic Medicines (2000), IMCOPS, Chennai.
5. Homeopathic Pharmacopoeia. Formulary of Homeopathic Medicines (2004), IMCOPS,
Chennai.
6. Homeopathic Pharmacy An introduction & Hand book by Steven B. Kayne (1997), Churchill
Livingstone, New York.
8. British Herbal Pharmacopoeia British (1990), Herbal Medicine Association, UK.
9. GMP for Botanicals - Regulatory and Quality issues on Phytomedicine by Pulok K Mukharjee
(2003), First edition, Business Horizons, New Delhi.
10. Indian System of Medicine and Homeopathy in India (2001), Planning and Evaluation Cell,
Govt.of India, New Delhi.
11. Essential of Food and Nutrition by Swaminathan (1999), Bappco, Bangalore.
12. Clinical Dietitics and Nutrition by F.P. Antia (1997), 4th Edi, Oxford Universith Press,
Delhi.
13. Yoga- The Science of Holistic Living by V.K.Yoga (2005), Vivekananda Yoga Prakashna
Publishing, Bangalore.
HERBAL COSMETICS (MPG204T)
Scope
This subject deals with the study of preparation and standardization of herbal/natural cosmetics.
This subject gives emphasis to various national and international standards prescribed regarding
Drug and cosmetic act.
Objective
After completion of the course, student is able to
 Understand the basic principles of various herbal/natural cosmetic preparations
 Current Good Manufacturing Practices of herbal/natural cosmetics as per the regulatory
authorities
THEORY
60Hrs
1. Introduction: Herbal/natural cosmetics, Classification& Economic aspects. Regulatory
Provisions relation to manufacture of cosmetics: - License, GMP, offences & Penalties, Import &
Export of Herbal/natural cosmetics, Industries involved in the production of Herbal/natural
cosmetics.
12 Hrs
2. Herbal Cosmetics for the skin: Physiology and chemistry of skin and pigmentation, hairs,
scalp, oral and nail, Cleansing cream, Lotions, Vanishing and Foundation creams, Anti- sun burn
preparations, Moisturizing cream , deodorants, Face powders, Face packs, Lipsticks, Bath
products, soaps and baby product, Preparation and standardisation of the following : Shampoos,
Conditioners, Tonic, Bleaches, Colorants, Depilatories and Hair oils, Dentifrices and Mouth
washes & Tooth Pastes, Cosmetics for Nails. 12 Hrs
3. Cosmeceuticals of herbal and natural origin: Hair growth formulations, Fairness
formulations. 12 Hrs
4. Commonly used herbal cosmetics, raw materials, preservatives, surfactants, humectants, oils,
colours, and some functional herbs, preformulation studies, compatibility studies, possible
interactions between chemicals and herbs, design of herbal cosmetic formulation.
12 Hrs
5. Analysis of Cosmetics, Toxicity screening and test methods: Quality control and toxicity
studies as per Drug and Cosmetics acts.
12 Hrs
REFERENCES:
 Panda H. 2007. Herbal Cosmetics (Hand book), Edition I, Asia Pacific Business Press Inc,
New Delhi.
 Thomson EG. 2006. Modern Cosmetics, Edition I, Universal Publishing Corporation,
Mumbai.
 P.P.Sharma. 2008. Cosmetics- Formulation, Manufacturing & Quality Control, Edition 4,
Vandana Publications, New Delhi.
 Supriya K B. 2005. Handbook of Aromatic Plants, Edition II(Revised and Enlarged), Pointer
Publishers, Jaipur.
 Skaria P. 2007. Aromatic Plants (Horticulture Science Series Vol. 1) , Edition I, New India
Publishing Agency, New Delhi.
 Kathi Keville and Mindy Green.1995. Aromatheraphy ( A Complete Guide to the Healing
Art), Edition I, Sri Satguru Publications, New Delhi.
 Chattopadhyay PK. 2000. Herbal Cosmetics & Ayurvedic Medicines (EOU), Edition I,
National Institute of Industrial Research, Delhi.
 Balsam MS & Edward Sagarin. 2008. Cosmetics Science and Technology, Edition II (Vol-II),
Wiley Interscience, New York.
PHARMACOGNOSY PRACTICAL-II (MPG205P)
1. Isolation of nucleic acid from cauliflower heads

2. Isolation of RNA from yeast
3. Quantitative estimation of DNA
4. Immobilization of whole cell
5. Establishment of callus culture
6. Establishment of suspension culture
7. Estimation of aldehyde
8. Estimation of phenolic content in herbal raw materials
9. Estimation of alkaloid content in herbal raw materials
10. Estimation of flavonoid content in herbal raw materials
11. Preparation and standardization of various simple dosage forms from Ayurvedic, siddha,
homoeopathy and Unani formulary
12. Preparation of certain Aromatherapy formulations
13. Herbal cosmetic formulation such as lip balm, lipstick, facial cream, herbal hair and nail care
products
14. Evaluation of herbal tablets and capsules
15. Dermatological preparation like sunscreen, UV protection cream, skin care formulations for
fungal and dermato reaction
16. Formulation of cough syrup
M. PHARM. PHARMACOLOGY (MPC)
SEMESTER-1

Scope
characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR,
HPLC, GC etc.
Objectives
 Theoretical and practical skills
THEORY 60 HOURS
1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-
Visible spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible
spectroscopy.
Dispersive and Fourier - Transform IR Spectrometer, Factors affecting vibrational frequencies
and Applications of IR spectroscopy
Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence, Quenchers,
Instrumentation and Applications of fluorescence spectrophotometer.
Flame emission spectroscopy and Atomic absorption spectroscopy: Principle,
Instrumentation, Interferences and Applications.
12 Hrs
NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation,
Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical
shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear
magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR. Applications
of NMR spectroscopy.
12 Hrs
3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types
of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI
Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions,
Isotopic peaks and Applications of Mass spectroscopy
12 Hrs
4 Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors
affecting resolution and applications of the following:
a) Paper chromatography b) Thin Layer chromatography c) Ion exchange chromatography d)
Column chromatography e) Gas chromatography f) High Performance Liquid chromatography g)
Affinity chromatography
12 Hrs
5 Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation
and applications of the following: a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric
focusing.
X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s law, Rotating
crystal technique, X ray powder technique, Types of crystals and applications of X-ray
diffraction.
12 Hrs
REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition, John
Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman,
5th edition, Eastern press, Bangalore, 1998.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS
7. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel
Dekker Series
ADVANCED PHARMACOLOGY-I (MPL101T)

Scope
The subject is designed to strengthen the basic knowledge in the field of pharmacology and to
impart recent advances in the drugs used for the treatment of various diseases. In addition, this
subject helps the students to understand the concepts of drug action and mechanisms involved
Objectives
Upon completion of the course the student shall be able to:
 Discuss the pathophysiology and pharmacotherapy of certain diseases
 Explain the mechanism of drug actions at cellular and molecular level
 Understand the adverse effects, contraindications and clinical uses of drugs used in treatment
of diseases
THEORY 60HOURS
UNIT-I
General Pharmacology
12 Hrs
a. Pharmacokinetics: The dynamics of drug absorption, distribution, biotransformation and
elimination. Concepts of linear and non-linear compartment models. Significance of Protein
binding. 06 hrs
b. Pharmacodynamics: Mechanism of drug action and the relationship between drug
concentration and effect. Receptors, structural and functional families of receptors, quantitation
of drug receptors interaction and elicited effects. 06 hrs
UNIT-II
12 Hrs
Neurotransmission
06 Hrs
a. General aspects and steps involved in neurotransmission.
b. Neurohumoral transmission in autonomic nervous system (Detailed study about
neurotransmitters- Adrenaline and Acetyl choline).
c. Neurohumoral transmission in central nervous system (Detailed study about neurotransmitters-
histamine, serotonin, dopamine, GABA, glutamate and glycine].
d. Non adrenergic non cholinergic transmission (NANC). Co-transmission
Systemic Pharmacology
06 Hrs
A detailed study on pathophysiology of diseases, mechanism of action, pharmacology and
toxicology of existing as well as novel drugs used in the following systems
a. Autonomic Pharmacology
Parasympathomimetics and lytics, sympathomimetics and lytics, agents affecting neuromuscular
junction
UNIT-III
12 Hrs
Central nervous system Pharmacology
General and local anesthetics 02 hrs
Sedatives and hypnotics, drugs used to treat anxiety. 02 hrs
Depression, psychosis, mania, epilepsy, neurodegenerative diseases. 05 hrs
Narcotic and non-narcotic analgesics. 03 hrs
UNIT-IV
Cardiovascular Pharmacology
12 Hrs
Diuretics, antihypertensives, antiischemics, anti- arrhythmics, drugs for heart failure
and hyperlipidemia. 07 hrs
Hematinics, coagulants , anticoagulants, fibrinolytics and anti-platelet drugs 05 hrs
UNIT- V
Autocoid Pharmacology
12 Hrs
The physiological and pathological role of Histamine, Serotonin, Kinins Prostaglandins
Opioid autocoids. 08 hrs
Pharmacology of antihistamines, 5HT antagonists. 04 hrs
REFEERENCES
1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s
2. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by David E Golan et
al.
3. Basic and Clinical Pharmacology by B.G -Katzung
4. Pharmacology by H.P. Rang and M.M. Dale.
6. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
6. Text book of Therapeutics, drug and disease management by E T. Herfindal and Gourley.
7. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for
Industrial Scientists
PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-I

(MPL102T)
Scope
This subject is designed to impart the knowledge on preclinical evaluation of drugs and recent
experimental techniques in the drug discovery and development. The subject content helps the
student to understand the maintenance of laboratory animals as per the guidelines, basic
knowledge of various in-vitro and in-vivo preclinical evaluation processes
Objectives
Upon completion of the course the student shall be able to,
 Appraise the regulations and ethical requirement for the usage of experimental animals.
 Describe the various animals used in the drug discovery process and good laboratory practices
in maintenance and handling of experimental animals
 Describe the various newer screening methods involved in the drug discovery process
 Appreciate and correlate the preclinical data to humans
THEORY 60 HOURS
Unit-I
12 Hrs
Laboratory Animals
Common lab animals: Description, handling and applications of different species and strains of
animals. 02 hrs
Transgenic animals: Production, maintenance and applications 02 hrs
Anaesthesia and euthanasia of experimental animals. 03 hrs
Maintenance and breeding of laboratory animals. 02 hrs
CPCSEA guidelines to conduct experiments on animals 02 hrs
Good laboratory practice. 01 hrs
Unit-II
12 Hrs
Preclinical screening of new substances for the pharmacological activity using in vivo, in
vitro, and other possible animal alternative models.
General principles of preclinical screening. CNS Pharmacology: behavioral and muscle co
ordination, CNS stimulants and depressants, anxiolytics, anti-psychotics, anti epileptics and
nootropics. Drugs for neurodegenerative diseases like Parkinsonism, Alzheimers and multiple
sclerosis. Drugs acting on Autonomic Nervous System.
Unit-III
12 Hrs
Respiratory Pharmacology: anti-asthmatics, drugs for COPD and anti allergics. Reproductive
Pharmacology: Aphrodisiacs and antifertility agents Analgesics, antiinflammatory and
antipyretic agents. Gastrointestinal drugs: anti ulcer, anti -emetic, anti-diarrheal and laxatives.
Unit-IV
12 hrs
Cardiovascular Pharmacology: antihypertensives, antiarrythmics, antianginal, antiatherosclerotic
agents and diuretics. Drugs for metabolic disorders like anti-diabetic, antihyperlipidemic, and
agents. Anti cancer agents
Unit V
12 hrs
Immunosuppressants and immunomodulators 02 hrs
General principles of immunoassay: theoretical basis and optimization of immunoassay,
heterogeneous and homogenous immunoassay systems. Immunoassay methods evaluation;
protocol outline, objectives and preparation. Immunoassay for digoxin and insulin 08 hrs
Limitations of animal experimentation and alternate animal experiments. 01 hr
Extrapolation of in vitro data to preclinical and preclinical to humans. 01 hr
REFERENCES
1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin
2. Indian Pharmacopeia and other Pharmacopeias
3. Screening methods in Pharmacology by Robert Turner. A
4. Evaluation of drugs activities by Laurence and Bachrach
5. Methods in Pharmacology by Arnold Schwartz.
6. Fundamentals of experimental Pharmacology by M.N.Ghosh
7. Pharmacological experiment on intact preparations by Churchill Livingstone
8. Drug discovery and Evaluation by Vogel H.G.
9. Experimental Pharmacology by R.K.Goyal.
10. Preclinical evaluation of new drugs by S.K. Gupta
CELLULAR AND MOLECULAR PHARMACOLOGY (MPL103T)

Scope:
The subject imparts a fundamental knowledge on the structure and functions of cellular
components and help to understand the interaction of these components with drugs. This
information will further help the student to apply the knowledge in drug discovery process
Objectives:
Upon completion of the course, the student shall be able to,
 Explain the receptor signal transduction processes.
 Explain the molecular pathways affected by drugs.
 Appreciate the applicability of molecular pharmacology and biomarkers in drug discovery
process.
 Demonstrate molecular biology techniques as applicable for pharmacology
Unit I
12 Hrs
Cell biology
Structure and functions of cell and its organelles Genome organization. Gene expression and its
regulation, importance of siRNA and micro RNA, gene mapping and gene sequencing Cell
cycles and its regulation. Cell death– events, regulators, intrinsic and extrinsic pathways of
apoptosis. Necrosis and autophagy.
Unit II
12Hrs
Cell signaling
Intercellular and intracellular signaling pathways. Classification of receptor family and
molecular structure ligand gated ion channels; Gprotein coupled receptors, tyrosine kinase
receptors and nuclear receptors. Secondary messengers: cyclic AMP, cyclic GMP, calcium ion,
inositol 1,4,5- trisphosphate, (IP3), NO, and diacylglycerol. Detailed study of following
intracellular signaling pathways: cyclic AMP signaling pathway, mitogen-activated protein
kinase (MAPK) signaling, Janus kinase (JAK)/signal transducer and activator of transcription
(STAT) signaling pathway.
Unit III
12Hrs
Principles and applications of genomic and proteomic tools 06 hrs
DNA electrophoresis, PCR (reverse transcription and real time), Gene sequencing, micro array
technique, SDS page, ELISA and western blotting,
Recombinant DNA technology and gene therapy 06 hrs
Basic principles of recombinant DNA technology-Restriction enzymes, various types of vectors.
Applications of recombinant DNA technology. Gene therapy- Various types of gene transfer
techniques, clinical applications and recent advances in gene therapy
Unit IV
12Hrs
Pharmacogenomics 08 hrs
Gene mapping and cloning of disease gene.
Genetic variation and its role in health/ pharmacology
Polymorphisms affecting drug metabolism
Genetic variation in drug transporters
Genetic variation in G protein coupled receptors
Applications of proteomics science: Genomics, proteomics, metabolomics, functionomics,
nutrigenomics 04 hrs
Types of immunotherapeutics, humanisation antibody therapy, Immunotherapeutics in clinical
practice
Unit V
12Hrs
Cell culture techniques
Basic equipments used in cell culture lab. Cell culture media, various types of cell culture,
general procedure for cell cultures; isolation of cells, subculture, cryopreservation,
characterization of cells and their application.
Principles and applications of cell viability assays, glucose uptake assay, Calcium influx assays
Principles and applications of flow cytometry
Unit VI
Biosimilars
References:
1. The Cell, A Molecular Approach. Geoffrey M Cooper.
2. Pharmacogenomics: The Search for Individualized Therapies. Edited by J. Licinio and M -L.
Wong
Immunotherapeutics
3. Handbook of Cell Signaling (Second Edition) Edited by Ralph A. et.al
4. Molecular Pharmacology: From DNA to Drug Discovery. John Dickenson et.al
5. Basic Cell Culture protocols by Cheril D.Helgason and Cindy L.Miller
6. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor)
7. Animal Cell Culture: A Practical Approach by John R. Masters (Editor)
8. Current porotocols in molecular biology vol I to VI edited by Frederick M.Ausuvel et la.
PHARMACOLOGY PRACTICAL-I (MPL104P)
1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer

spectrophotometry
Handling of laboratory animals.
1. Various routes of drug administration.
2. Techniques of blood sampling, anesthesia and euthanasia of experimental animals.
3. Functional observation battery tests (modified Irwin test)
4. Evaluation of CNS stimulant, depressant, anxiogenics and anxiolytic, anticonvulsant activity.
5. Evaluation of analgesic, anti-inflammatory, local anesthetic, mydriatic and miotic activity.
6. Evaluation of diuretic activity.
7. Evaluation of antiulcer activity by pylorus ligation method.
8. Oral glucose tolerance test.
9. Isolation and identification of DNA from various sources (Bacteria, Cauliflower, onion, Goat
liver).
10. Isolation of RNA from yeast
11. Estimation of proteins by Braford/Lowry’s in biological samples.
12. Estimation of RNA/DNA by UV Spectroscopy
13. Gene amplification by PCR.
14. Protein quantification Western Blotting.
15. Enzyme based in-vitro assays (MPO, AChEs, α amylase, α glucosidase).
16. Cell viability assays (MTT/Trypan blue/SRB).
17. DNA fragmentation assay by agarose gel electrophoresis.
18. DNA damage study by Comet assay.
19. Apoptosis determination by fluorescent imaging studies.
20. Pharmacokinetic studies and data analysis of drugs given by different routes of
administration using softwares
21. Enzyme inhibition and induction activity
22. Extraction of drug from various biological samples and estimation of drugs in biological
fluids using different analytical techniques (UV)
23. Extraction of drug from various biological samples and estimation of drugs in biological
fluids using different analytical techniques (HPLC)
References
1. CPCSEA, OECD, ICH, USFDA, Schedule Y, EPA guidelines,
2. Fundamentals of experimental Pharmacology by M.N.Ghosh
3. Handbook of Experimental Pharmacology by S.K. Kulkarni.
4. Drug discovery and Evaluation by Vogel H.G.
5. Spectrometric Identification of Organic compounds - Robert M Silverstein,
7. Vogel‘s Text book of quantitative chemical analysis - Jeffery, Basset, Mendham, Denney,
8. Basic Cell Culture protocols by Cheril D. Helgason and Cindy L.Mille
9. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor)
10. Animal Cell Culture: A Practical Approach by John R. Masters (Editor)
SEMESTER-II
ADVANCED PHARMACOLOGY-II (MPL201T)

Scope
The subject is designed to strengthen the basic knowledge in the field of pharmacology and to
impart recent advances in the drugs used for the treatment of various diseases. In addition, the
subject helps the student to understand the concepts of drug action and mechanism involved
Objectives
 Explain the mechanism of drug actions at cellular and molecular level
 Discuss the Pathophysiology and pharmacotherapy of certain diseases
 Understand the adverse effects, contraindications and clinical uses of drugs used in treatment
of diseases
UNIT-I
Endocrine Pharmacology 12 Hrs
Molecular and cellular mechanism of action of hormones such as growth hormone, prolactin,
thyroid, insulin and sex hormones
Anti-thyroid drugs, Oral hypoglycemic agents, Oral contraceptives, Corticosteroids.
Drugs affecting calcium regulation
UNIT-II
Chemotherapy 12 Hrs
Cellular and molecular mechanism of actions and resistance of antimicrobial agents such as ß-
lactams, aminoglycosides, quinolones, Macrolide antibiotics. Antifungal, antiviral, and anti-TB
drugs.
UNIT-III 12 Hrs
Chemotherapy 06 Hrs
Drugs used in Protozoal Infections
Drugs used in the treatment of Helminthiasis
Chemotherapy of cancer
Immunopharmacology 06 Hrs
Cellular and biochemical mediators of inflammation and immune response. Allergic or
hypersensitivity reactions. Pharmacotherapy of asthma and COPD.
Immunosuppressants and Immunostimulants
UNIT-IV
GIT Pharmacology 08 Hrs
Antiulcer drugs, Prokinetics, antiemetics, anti-diarrheals and drugs for constipation and irritable
bowel syndrome.
Chronopharmacology 04 Hrs
Biological and circadian rhythms, applications of chronotherapy in various diseases like
cardiovascular disease, diabetes, asthma and peptic ulcer
UNIT-V
Free radicals Pharmacology 04 Hrs
Generation of free radicals, role of free radicals in etiopathology of various diseases such as
diabetes, neurodegenerative diseases and cancer.
Protective activity of certain important antioxidant
Recent Advances in Treatment: 08 Hrs

Alzheimer ’s disease, Parkinson’s disease , Cancer, Diabetes mellitus
References
1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s
2. Principles of Pharmacology. The Pathophysiologic basis of drug therapy by David E Golan et
al.
3. Basic and Clinical Pharmacology by B.G -Katzung
4. Pharmacology by H.P. Rang and M.M. Dale.
5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
6. Text book of Therapeutics, drug and disease management by E T. Herfindal and Gourley.
Industrial Scientists
PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

(MPL202T)
Scope:
The subject imparts knowledge on the preclinical safety and toxicological evaluation of drug &
new chemical entity. This knowledge will make the student competent in regulatory
toxicological evaluation.
Objectives:
 Explain the various types of toxicity studies.
 Appreciate the importance of ethical and regulatory requirements for toxicity studies.
 Demonstrate the practical skills required to conduct the preclinical toxicity studies.
Unit I
12 Hrs
Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive)
Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y OECD
principles of Good laboratory practice (GLP)
History, concept and its importance in drug development
Unit II
12 Hrs
Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD guidelines.
Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies.
Test item characterization- importance and methods in regulatory toxicology studies
Unit III
12 Hrs
Reproductive toxicology studies, Male reproductive toxicity studies, female reproductive studies
(segment I and segment III), teratogenecity studies (segment II)
Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus and Chromosomal
aberrations studies)
In vivo carcinogenicity studies
Unit IV
12 Hrs
IND enabling studies (IND studies)- Definition of IND, importance of IND, industry perspective,
list of studies needed for IND submission.
Safety pharmacology studies- origin, concepts and importance of safety pharmacology.
Tier1- CVS, CNS and respiratory safety pharmacology, HERG assay. Tier2- GI, renal and other
studies
Unit V
12 Hrs
Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics
Importance and applications of toxicokinetic studies.
Alternative methods to animal toxicity testing.
REFERENCES
1. Hand book on GLP, Quality practices for regulated non-clinical research and development
(http://www.who.int/tdr/publications/documents/glp-handbook.pdf).
2. Schedule Y Guideline: drugs and cosmetics (second amendment) rules, 2005, ministry of
health and family welfare (department of health) New Delhi
3. Drugs from discovery to approval by Rick NG.
4. Animal Models in Toxicology, 3rd Edition, Lower and Bryan
5. OECD test guidelines.
6. Principles of toxicology by Karen E. Stine, Thomas M. Brown.
7. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for Pharmaceuticals
(http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/
ucm073246.pdf)
PRINCIPLES OF DRUG DISCOVERY (MPL203T)

Scope:
The subject imparts basic knowledge of drug discovery process. This information will make the
student competent in drug discovery process
Objectives:
 Explain the various stages of drug discovery.
 Appreciate the importance of the role of genomics, proteomics and bioinformatics in drug
discovery
 Explain various targets for drug discovery.
 Explain various lead seeking method and lead optimization
 Appreciate the importance of the role of computer aided drug design in drug discovery
Unit-I
12 Hrs
An overview of modern drug discovery process: Target identification, target validation, lead
identification and lead Optimization. Economics of drug discovery.
Target Discovery and validation-Role of Genomics, Proteomics and Bioinformatics. Role of
Nucleic acid microarrays, Protein microarrays, Antisense technologies, siRNAs, antisense
oligonucleotides, Zinc finger proteins. Role of transgenic animals in target validation.
Unit-II
12 Hrs
Lead Identification- combinatorial chemistry & high throughput screening, in silico lead
discovery techniques, Assay development for hit identification.
Protein structure Levels of protein structure, Domains, motifs, and folds in protein structure.
Computational prediction of protein structure: Threading and homology modeling methods.
Application of NMR and X-ray crystallography in protein structure prediction
Unit-III
12 Hrs
Rational Drug Design Traditional vs rational drug design, Methods followed in traditional drug
design, High throughput screening, Concepts of Rational Drug Design, Rational Drug Design
Methods: Structure and Pharmacophore based approaches Virtual Screening techniques: Drug
likeness screening, Concept of pharmacophore mapping and pharmacophore based Screening,
Unit-IV
12 Hrs
Molecular docking: Rigid docking, flexible docking, manual docking; Docking based screening.
De novo drug design. Quantitative analysis of Structure Activity Relationship History and
development of QSAR, SAR versus QSAR, Physicochemical parameters, Hansch analysis, Fee
Wilson analysis and relationship between them.
Unit-V
12 Hrs
QSAR Statistical methods – regression analysis, partial least square analysis (PLS) and other
multivariate statistical methods. 3D-QSAR approaches like COMFA and COMSIA Prodrug
design-Basic concept, Prodrugs to improve patient acceptability, Drug solubility, Drug
absorption and distribution, site specific drug delivery and sustained drug action. Rationale of
prodrug design and practical consideration of prodrug design
References
1. MouldySioud. Target Discovery and Validation Reviews and Protocols: Volume 2 Emerging
Molecular Targetsand Treatment Options. 2007 Humana Press Inc.
2. Darryl León. Scott MarkelIn. Silico Technologies in Drug Target Identification and
Validation. 2006 by Taylor and Francis Group, LLC.
3. Johanna K. DiStefano. Disease Gene Identification. Methods and Protocols. Springer New
York Dordrecht Heidelberg London.
4. Hugo Kubiny. QSAR: Hansch Analysis and Related Approaches. Methods and Principles in
Medicinal Chemistry. Publisher Wiley-VCH
5. Klaus Gubernator, Hans-Joachim Böhm. Structure-Based Ligand Design. Methods and
Principles in Medicinal Chemistry. Publisher Wiley-VCH
6. Abby L . Parrill. M . Rami Reddy. Rational Drug Design. Novel Methodology and Practical
Applications. ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
7. J. Rick Turner. New drug development design, methodology and, analysis. John Wiley &
Sons, Inc., Hoboken, New Jeney.
CLINICAL RESEARCH AND PHARMACOVIGILANCE (MPL204T)

Scope:
This subject will provide a value addition and current requirement for the students in clinical
research and pharmacovigilance. It will teach the students on conceptualizing, designing,
conducting, managing and reporting of clinical trials. This subject also focuses on global
scenario of Pharmacovigilance in different methods that can be used to generate safety data. It
will teach the students in developing drug safety data in Pre-clinical, Clinical phases of Drug
development and post market surveillance.
Objectives:
 Explain the regulatory requirements for conducting clinical trial
 Demonstrate the types of clinical trial designs
 Explain the responsibilities of key players involved in clinical trials
 Execute safety monitoring, reporting and close-out activities
 Explain the principles of Pharmacovigilance
 Detect new adverse drug reactions and their assessment
 Perform the adverse drug reaction reporting systems and communication in
Pharmacovigilance
UNIT-I
12 hours
Regulatory Perspectives of Clinical Trials:
Origin and Principles of International Conference on Harmonization - Good Clinical Practice
(ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for
Biomedical Research and Human Participant-Schedule Y, ICMR
Informed Consent Process: Structure and content of an Informed Consent Process Ethical
principles governing informed consent process
UNIT- II
12 hours
Clinical Trials: Types and Design
Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross
sectional
Clinical Trial Study Team
Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor,
Contract Research Organization and its management
UNIT- III
12 hours
Clinical Trial Documentation- Guidelines to the preparation of documents, Preparation of
protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial
Monitoring-Safety Monitoring in CT
Adverse Drug Reactions: Definition and types. Detection and reporting methods. Severity and
seriousness assessment.Predictability and preventability assessment, Management of adverse
drug reactions; Terminologies of ADR.
UNIT-IV
12 hours
Basic aspects, terminologies and establishment of pharmacovigilance
History and progress of pharmacovigilance, Significance of safety monitoring,
Pharmacovigilance in India and international aspects, WHO international drug monitoring
programme, WHO and Regulatory terminologies of ADR, evaluation of medication safety,
Establishing pharmacovigilance centres in Hospitals, Industry and National programmes related
to pharmacovigilance. Roles and responsibilities in Pharmacovigilance
UNIT-V
12 hours
Methods, ADR reporting and tools used in Pharmacovigilance
International classification of diseases, International Non-proprietary names for drugs, Passive
and Active surveillance, Comparative observational studies, Targeted clinical investigations and
Vaccine safety surveillance. Spontaneous reporting system and Reporting to regulatory
authorities, Guidelines for ADRs reporting. Argus, Aris G Pharmacovigilance, VigiFlow,
Statistical methods for evaluating medication safety data.
UNIT-VI
Pharmacoepi Dermatology , pharmacoeconomics , safety pharmacology
References:
1. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical
Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;2001.
2. International Conference on Harmonization of Technical requirements for registration of
Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good
Clinical Practice.E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of
Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March
2005, John Wiley and Sons.
5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition,
Jan 2000, Wiley Publications.
6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone.
7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
PHARMACOLOGY PRACTICAL-II (MPL205P)
1. To record the DRC of agonist using suitable isolated tissues preparation.

2. To study the effects of antagonist/potentiating agents on DRC of agonist using suitable
isolated tissue preparation.
3. To determine to the strength of unknown sample by matching bioassay by using suitable tissue
preparation.
4. To determine to the strength of unknown sample by interpolation bioassay by using suitable
tissue preparation
5. To determine to the strength of unknown sample by bracketing bioassay by using suitable
tissue preparation
6. To determine to the strength of unknown sample by multiple point bioassay by using suitable
tissue preparation.
7. Estimation of PA2 values of various antagonists using suitable isolated tissue preparations.
8. To study the effects of various drugs on isolated heart preparations
9. Recording of rat BP, heart rate and ECG.
10. Recording of rat ECG
11. Drug absorption studies by averted rat ileum preparation.
12. Acute oral toxicity studies as per OECD guidelines.
13. Acute dermal toxicity studies as per OECD guidelines.
14. Repeated dose toxicity studies- Serum biochemical, haematological, urine analysis,
functional observation tests and histological studies.
15. Drug mutagenicity study using mice bone-marrow chromosomal aberration test.
16. Protocol design for clinical trial.
19. Design of ADR monitoring protocol.
20. In silico docking studies.
21. In silico pharmacophore based screening.
22. In silico QSAR studies.
23. ADR reporting
24. In silico docking studies.
References
1. Fundamentals of experimental Pharmacology-by M.N.Ghosh
2. Hand book of Experimental Pharmacology-S.K.Kulakarni
3. Text book of in-vitro practical Pharmacology by Ian Kitchen
4. Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal choudhary and
William Thomsen
Industrial Scientists.
M.PHARM. DRUG REGULATORY AFFAIRS (DRA)
SEMESTER-1
GOOD PHARMACEUTICAL PRACTICES (DRA 101T)

Scope
This course is designed to impart fundamental knowledge biological and medical devices on
various Good Regulatory Practices viz., cGMP, GLP, GALP and GDP pharmaceutical industries
and understand the rationale behind these requirements and will propose ways and means of
complying them.
Objectives
 The key elements of current Good Manufacturing Practices, Good Laboratory Practices, Good
Automated Laboratory Practices, Good Documentation Practices
 The check lists for various Good Regulatory Practices and
 Prepare SOPs for Good Pharmaceutical Practices
 Implement Good Regulatory Practices in the Health care Industries and
 Prepare for the Audit of the Pharmaceutical Industries.
 Prepare for the rediness and conduct of the audit/inspections
THEORY 60Hrs
1. Current Good Manufacturing Practices: Introduction, US cGMP Part 210 and Part 211.EC
Principles of GMP (Directive 91/356/EEC) Article 6 to Article 14 and WHO cGMP guidelines
GAMP-5; Medical devices, GHTF guidance docts
12Hrs
2. Good Laboratory Practices: Introduction,USFDA GLP Regulations (Subpart A to Subpart
K),Controlling the GLP inspection process,GLP Documentation,Audit, goals of Laboratory
Quality Audit, Audit tools, Future of GLP regulations, ISO
12Hrs
3. Good Automated Laboratory Practices: Introduction to GALP, Principles of GALP, GALP
Requirements, SOPs of GALP, Training Documentation,21 CFR Part 11,General check list of
21CFR Part 11, Software Evaluation checklist, ISO.
12Hrs
4. Good Distribution Practices: Introduction to GDP, Legal GDP requirements put worldwide,
Principles, Personnel, Documentation, Premises and Equipment, Deliveries to Customers,
Returns, Self Inspection, Provision of information, Stability testing principles, WHO GDP, USP
GDP( Supply chain integrity), GHTF guidance/IMDRF/CDSCO
12Hrs
5. Quality management systems: Concept of Quality, Total Quality Management, Quality by
design, Six Sigma concept, Out of Specifications (OOS), Change control. Validation: Types of
Validation, Types of Qualification, Validation master plan (VMP), Analytical Method
Validation. Validation of utilities, [Compressed air, steam, water systems, Heat Ventilation and
Air conditioning (HVAC)]and Cleaning Validation. The International Conference on
Harmonization (ICH) process, ICH guidelines to establish quality, safety and efficacy of drug
substances and products, ISO 13485, Schedule M III
12Hrs
REFERENCES
1. Good Laboratory Practice Regulations, by Sandy Weinberg, Fourth Edition,Drugs and the
Pharmaceutical Sciences, Vol.168
2. Good Pharmaceutical Manufacturing practice, Rational and compliance by John Sharp, CRC
Press
3. Establishing a cGMP Laboratory Audit System, A practical Guide by David M.Bleisner,
Wiley Publication.
4. How to practice GLP by PP Sharma, Vandana Publications.
5. Laboratory Auditing for Quality and Regulatory compliance bu Donald C.Singer, Drugs and
the Pharmaceutical Sciences, Vol.150.
PHARMACEUTICAL REGULATIONS IN INDIA (DRA 102T)

Scope:
This course is designed to impart fundamental knowledge on regulations and legislations in India
with respect to PMBC. It prepares the students for basic regulatory requirements in India of PMB
for manufacture, import, registration, export, sale, marketing authorization, clinical trials and
intellectual property rights.
Objectives:
Upon the completion of the course the student shall be able to:
 Know different Acts and guidelines that regulate PMBC industry in India.
 Understand the approval process and regulatory requirements for drugs and medical devices
THEORY 60 HOURS
UNIT I
 Study of Relevant provisions of FPMBC
 Acts and Rules (with latest amendments):
 Drugs and Cosmetics Act 1940 and other Relevant provisions (Rules, Schedules and
Guidelines) for approval of FPMBC , Rules 1945: DPCO and NPPA
 Legal definitions of schedules to the Act and Rules, Import of drugs, Manufacture of drugs,
Sale of Drugs& Packing of drugs & other related Acts-Narcotic etc Central Drug Standard
Control Organization and State Licensing Authority:
1. Rules, Regulations, Guidelines For Regulatory filling of FPMB to Relevant Regulations
2. Fomat and contents of Regulatory dossier filling
3. Clinical trials /Investigations
 Clinical Trials
 New Drugs
 Medical Devices
 Fixed Dose Combinations
12 Hrs
UNIT II
Regulatory requirements FNPCMB and approval procedures for:
12 Hrs
UNIT III
Indian Pharmacopoeial standards
 BIS Standards & ISO and other relevant standards
UNIT IV
BA/ BE: Bioavailability and Bioequivalence data, BCS Classification of Drugs, Regulatory
Requirements for Bioequivalence study
Stability requirements: ICH and WHO
Guidelines for drug testing in animals/Preclinical studies
 Animal testing: Rationale for conducting studies, CPCSEA Guidelines
 ethical guidelines for human participants
 ICMR-DBT Guidelines for Stem Cell Research
12 Hrs
UNIT V
Intellectual Property Rights: Patent, Trademark, Copyright, Industrial Designs and
Geographical Indications, Indian Patent Scenario. IPR vs Regulatory Affairs
12 Hrs
REFERENCES
1. Manual of Patent Practice & Procedure, 3rd Edition, by The Patent Office of India
2. Patent Failure How Judges, Bureaucrats, and Lawyers put innovators at risk by James Bessen
and Michael J. Meurer
3. Principles and Practice of Clinical Trial Medicine by Richard Chin and Bruce Y. Lee
4. Ethical Guidelines for Biomedical Research on Human Participants by Indian Council of
Medical Research New delhi 2006.
5. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the purpose of control
and supervision on experiments on animals (CPCSEA)
6. ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite
7. Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and
Efficacy by CDSCO (Central Drug Standard Control Organisation)
8. Guidance for Industry on Requirement of Chemical & Pharmaceutical Information including
Stability Study Data before approval of clinical trials / BE studies by CDSCO
9. Guidelines for Import and Manufacture of Medical Devices by CDSCO
10. Guidelines from official website of CDSCO
INTERNATIONAL PHARMACEUTICAL REGULATIONS-I (DRA103T)

Scope:
This course is designed to impart the fundamental knowledge on the drug development general
regulatory requirements for approval of FNPCMB Japan. It prepares the students to have
elimentary knowledge on the regulatory requirements, documentation requirements, and
registration procedures for marketing the products in above countries.
Objectives: Upon completion of the course, the student shall be able to understand the
Regulatory registration and landscape
THEORY 60 Hours
Unit-I
12 Hours
USA and CANADA: Organization structure and functions of FDA. Federal register and Code of
Federal Regulations (CFR), History and evolution of United States Federal, Food, Drug and
Cosmetic Act (FFDCA), Hatch Waxman act and Orange book, Purple book, Drug Master Files
(DMF) system in US, Regulatory Approval Process for Investigational New Drug (IND), New
Drug Application (NDA), Abbreviated New Drug Application (ANDA), Supplemental New
Drug Application (SNDA); Regulatory requirements for Orphan drugs and Combination
Products, Changes to an approved NDA / ANDA. Regulatory considerations for manufacturing,
packaging and labeling of pharmaceuticals in USA
Unit-II
12 Hours
EUROPEAN UNION and AUSTRALIA: Organization and structure of EMA & EDQM,
General guidelines, Active Substance Master Files (ASMF) system in EU, Content and approval
process of IMPD, Marketing Authorization procedures in EU (Centralized procedure,
Decentralized procedure, Mutual recognition procedure and National Procedure). Regulatory
considerations for manufacturing, packaging and labeling of pharmaceuticals in EU, Eudralex
directives for human medicines, Variations & extensions, Compliance of European
Pharmacopoeia (CEP)/ Certificate of Suitability (CoS), Marketing Authorization (MA) transfers,
Qualified Person (QP) in EU
Unit-III
12 Hours
Japan: Organization of the PMDA, Pharmaceutical Laws and regulations, types of registration
applications, DMF system in Japan, drug regulatory approval process, Regulatory considerations
for manufacturing, packaging and labeling of pharmaceuticals in Japan, Post marketing
surveillance in Japan
UNIT IV
BRAZIL and CHINA
UNIT V
ASEAN and SOUTH ASIA
REFERENCES:
Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer,
Marcel Dekker series, Vol.143Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel
Dekker Series,Vol.144
1. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P.
Martin, Drugs and the Pharmaceutical Sciences,Vol.185 Informa Health care Publishers.
2. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD,
5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.
3. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
4. Drugs: From Discovery to Approval, Second Edition By Rick Ng
5. New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu
6. Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines and Gary H.
Slatko
7. Preparation and Maintenance of the IND Application in eCTD Format By William K.
Sietsema
8. Country Specific Guidelines from official websites.
CLINICAL RESEARCH REGULATIONS (DRA 104T)

Scope:
This course is designed to impart the fundamental knowledge on the clinical development
process of FNPCMB, phases and conduct of clinical trials and research, regulations and guidance
governing the conduct of clinical research in INDIA. It prepares the students to learn in detail on
various laws, legislations and guidance related to safety, efficacy, ethical conduct and regulatory
approval of clinical trials and investigations
Objectives: Upon completion of the course, the student shall be able to (know, do and
appreciate)
 Clinical drug development process and different phases of clinical trials, investigations
 History, origin and ethics of clinical research
 regulatory requirements for conducting clinical trials investigations and research
 regulations and guidance governing the conduct of clinical research,
THEORY 60 Hours
Unit-I
12 Hours
Basics for Clinical trials for drug development process
 Phases of clinical trials, Clinical Trial protocol
 Phase 0 studies
 Phase I and subtype studies (single ascending, multiple ascending, dose escalation, methods,
food effect studies, drug – drug interaction, PK end points
 Phase II studies (proof of concept or principle studies to establish efficacy)
 Phase III studies (Multi ethnicity, global clinical trial, registration studies)
 Phase IV studies (Post marketing authorization studies; pits and practices)
 Ethical principles governing informed consent process
 Patient Information Sheet and Informed Consent Form
 The informed consent process and documentation
Unit-II
12 Hours
Basic CT for MD Ethics in Clinical Research:
 Historical Perspectives: Nuremberg Code, Thalidomide study , Nazis Trials, Tuskegee
Syphilis
Study, The Belmont Report, The declaration of Helsinki
 Origin of International Conference on Harmonization - Good Clinical Practice (ICH-GCP)
guidelines.
 The ethics of randomized clinical trials
 The role of placebo in clinical trials
 Ethics of clinical research in special population
 Institutional Review Board/Independent Ethics Committee/Ethics Committee – composition,
roles, responsibilities, review and approval process and ongoing monitoring of safety data
212
 Data safety monitoring boards.
 Responsibilities of sponsor, CRO, and investigator in ethical conduct of clinical research
Unit-III
12 Hours
Regulations governing Clinical Trials
USA: Regulations to conduct drug studies in USA (FDA)
 NDA 505(b)(1) of the FD&C Act (Application for approval of a new drug)
 NDA 505(b)(2) of the FD&C Act (Application for approval of a new drug that relies, at least
in part, on data not developed by the applicant)
 ANDA 505(j) of the FD&C Act (Application for approval of a generic drug product)
 FDA Guidance for Industry - Acceptance of Foreign Clinical Studies
 FDA Clinical Trials Guidance Document: Good Clinical Practice
EU: Clinical Research regulations in European Union (EMA)
India: Clinical Research regulations in India – Schedule Y
Unit-IV
Clinical Research Related Guidelines 12 Hours
 Good Clinical Practice Guidelines (ICH GCP E6)
 Indian GCP Guidelines
 ICMR Ethical Guidelines for Biomedical Research
 CDSCO guidelines
Regulatory Guidance on Efficacy and Safety
ICH Guidance’s
 E4 – Dose Response Information to support Drug Registration
 E7 – Studies in support of General Population: Geriatrics
 E8 – General Considerations of Clinical Trials
 E10 – Choice of Control Groups and Related Issues in Clinical Trials,
 E 11 – Clinical Investigation of Medicinal Products in the Pediatric Population
Unit-V 12 Hours
USA & EU Guidance
USA: FDA Guidance
 CFR 21Part 50: Protection of Human Subjects
 CFR 21Part 54: Financial Disclosure by Clinical Investigators
 CFR 21Part 312: IND Application
 CFR 21Part 314: Application for FDA Approval to Market a New Drug
 CFR 21Part 320: Bioavailability and bioequivalence requirements
 CFR 21Part 812: Investigational Device Exemptions 213
 CFR 21Part 822: Post-market surveillance
 FDA Safety Reporting Requirements for INDs and BA/BE Studies
 FDA Med Watch
 Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic
Assessment
European Union: EMA Guidance
 EU Directives 2001
 EudraLex (EMEA) Volume 3 – Scientific guidelines for medicinal products for human use
 EU Annual Safety Report (ASR)
 Volume 9A – Pharmacovigilance for Medicinal Products for Human Use
REFERENCES:
1. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A.
Rozovsky and Rodney K. Adams
2. HIPAA and Human Subjects Research: A Question and Answer Reference Guide By Mark
Barnes, JD, LLM and Jennifer Kulynych, JD, PhD
3. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and
Frederick P. Ognibene
4. Reviewing Clinical Trials: A Guide for the Ethics Committee; Johan PE Karlberg and
Marjorie A Speers; Karlberg, Johan Petter Einar, Hong Kong.
5. International Pharmaceutical Product Registration: Aspects of Quality, Safety and Efficacy;
Anthony C. Cartwright; Taylor & Francis Inc., USA.
6. New Drug Approval Process: The Global Challenge; Guarino, Richard A; Marcel Dekker Inc.,
NY.
7. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics;
Douglas J. Pisano, David Mantus; CRC Press, USA
RECOMMENDED WEBSITES:
1. 1. EU Clinical Research Directive 2001: http://www.eortc.be/services/doc/clinical-eudirective-
04-april-01.pdf
2. Code of Federal Regulations
FDA:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
3. Guidelines of International Conference on Harmonization:
http://www.ich.org/products/guidelines.html
4. Eudralex Guidelines: http://www.gmpcompliance.info/euguide.htm
5. FDA New Drug Application:
http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct
/FDCActChapterVDrugsandDevices/ucm108125.htm
6. Medicines and Healthcare products Regulatory Agency: http://www.mhra.gov.uk 214
7. Central Drugs Standard Control Organization Guidance for Industry:
http://cdsco.nic.in/CDSCOGuidanceForIndustry. pdf
8. ICMR Ethical Guidelines for Biomedical Research: http://icmr.nic.in/ethical_guidelines.pdf
215
PHARMACEUTICAL REGULATORY AFFAIRS PRACTICAL-I (MRA105P)
1. Case studies (4 Nos.) of each of Good Pharmaceutical Practices.

2. Documentation for in process and finished products Quality control tests for Solid, liquid,
Semisolid and Sterile preparations.
3. Preparation of SOPs, Analytical reports (Stability and validation)
4. Protocol preparation for documentation of various types of records (BMR, MFR, DR)
5. Labeling comparison between brand & generics.
6. Preparation of clinical trial protocol for registering trial in India
7. Registration for conducting BA/ BE studies in India
8. Import of drugs for research and developmental activities
9. Preparation of regulatory dossier as per Indian CTD format
10. Registering for different Intellectual Property Rights in India
11. GMP Audit Requirements as per CDSCO
12. Preparation and documentation for Indian Patent application.
13. Preparation of checklist for registration of IND as per ICH CTD format.
14. Preparation of checklist for registration of NDA as per ICH CTD format.
15. Preparation of checklist for registration of ANDA as per ICH CTD format.
16. Case studies on response with scientific rationale to USFDA Warning Letter
17. Preparation of submission checklist of IMPD for EU submission.
18. Comparison study of marketing authorization procedures in EU.
19. Comparative study of DMF system in US, EU and Japan
20. Preparation of regulatory submission using eCTD software
21. Preparation of Clinical Trial Application (CTA) for US submission
22. Preparation of Clinical Trial Application (CTA) for EU submission
23. Comparison of Clinical Trial Application requirements of US, EU and Japan of a dosage
form.
24. Regulatory requirements checklist for conducting clinical trials in India.
25. Regulatory requirements checklist for conducting clinical trials in Europe.
26. Regulatory requirements checklist for conducting clinical trials in USA
216
SEMESTER-II
DOCUMENTATION AND REGULATORY WRITING (DRA 201T)

Scope
This course is designed to impart fundamental knowledge on documentation and general
principles involved in regulatory writing and submission to agencies.
Objectives
1. Know the various documents pertaining to drugs in pharmaceutical industry
2. Understand the basics of regulatory compilation
3. Create and assemble the regulation submission as per the requirements of agencies
4. Follow up the submissions and post approval document requirements
1. Documentation in pharmaceutical industry: Exploratory Product Development Brief (EPDB)
for Drug substance and Drug product, Product Development Plan (PDP), Product Development
Report (PDR), Master Formula Record, Batch Manufacturing Record and its calculations, Batch
Reconciliation, Batch Packaging Records, Print pack specifications, Distribution records,
Certificate of Analysis (CoA), Site Master File and Drug Master Files (DMF).
2. Dossier preparation and submission: Introduction and overview of dossiers, contents and
organization of dossier, binders and sections, compilation and review of dossier. Paper
submissions, overview and modules of CTD, electronic CTD submissions
Electronic submission: Planning electronic submission, requirements for submission, regulatory
bindings and requirements, Tool and Technologies, electronic dossier submission process and
validating the submission, Electronic Submission Gateway (ESG). Non eCTD electronic
submissions (NeeS), Asian CTD formats (ACTD) submission. Organizing, process and
validation of submission
3. Audits: Introduction, Definition, Summary, Types of audits, GMP compliance audit, Audit
policy, Internal and External Audits, Second Party Audits, External third party audits, Auditing
strategies, Preparation and conducting audit, Auditing strategies, audit analysis, audit report,
audit follow up. Auditing/inspection of manufacturing facilities by regulatory agencies.
Timelines for audits/inspection
4. Inspections: Pre-approval inspections, Inspection of pharmaceutical manufacturers, Inspection
of drug distribution channels, Quality systems requirements for national good manufacturing
practice inspectorates, inspection report, model certificate of good manufacturing practices, Root
cause analysis, Corrective and Preventive action (CAPA)
5. Product life cycle management: Prior Approval Supplement (PAS), Post Approval Changes
[SUPAC], Changes Being Effected in 30 Days (CBE-30), Annual Report, Post marketing
Reporting Requirements, Post approval Labeling Changes, Lifecycle Management, FDA
Inspection and Enforcement, Establishment Inspection Report (EIR), Warning Letters, Recalls,
Seizure and Injunctions
REFERENCES
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil Bismuth,
Interpharm/CRC, Boca Raton, London New York, Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox Gad.
Wiley- Interscience, A John Wiley and sons, Inc., Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman A. Hodges,
Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana
Stefan, Jacobus F. Van Staden. Taylor and Francis (2005).
5. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By Al
Endres, Wiley, 2000
6. Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases, By
Jiju Antony; David Preece, Routledge, 2002
7. Organizing for High Performance: Employee Involvement, TQM, Reengineering, and
Knowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler; Susan
Albers Mohrman; George Benson, Jossey-Bass, 2001
8. Corporate Culture and the Quality Organization By James W. Fairfield-Sonn, Quorum Books,
2001
9. The Quality Management Sourcebook: An International Guide to Materials and Resources By
Christine Avery; Diane Zabel, Routledge, 1997
10. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
11. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ
Publications
12. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes,
2009, ASQ Publications
BIOLOGICALS REGULATIONS (DRA 202T)
Scope
This course is designed to impart fundamental knowledge on Regulatory Requirements,
Licensing and Registration, Regulation on Labelling of Biologics in India, USA and Europe It
prepares the students to learn in detail on Regulatory Requirements for biologics, Vaccines and
Blood Products
Objectives
Upon the completion of the course the student shall be able to:
 Know the regulatory Requirements for Biologics and Vaccines
 Understand the regulation for newly developed biologics and biosimilars
 Know the pre-clinical and clinical development considerations of biologics
 Understand the Regulatory Requirements of Blood and/or Its Components Including Blood
Products and label requirements
Theory 60 Hrs
Unit I
1.India : Introduction, Applicable Regulations and Guidelines , Principles for Development of
Similar Biologics, Data Requirements for Preclinical Studies, Data Requirements for Clinical
Trial Application, Data Requirements for Market Authorization Application, Post-Market Data
for Similar Biologics, Pharmacovigilance. GMP and GDP.
12 Hrs
Unit II
2.USA: Introduction to Biologics; biologics, biological and biosimilars, different biological
products, difference between generic drug and biosimilars, laws, regulations and guidance on
biologics/ biosimilars, development and approval of biologics and biosimilars (IND, PMA, BLA,
NDA, 510(k), pre-clinical and clinical development considerations, advertising, labeling and
packing of biologics
12 Hrs
Unit III
3. European Union: Introduction to Biologics; directives, scientific guidelines and guidance
related to biologics in EU, comparability/ biosimilarity assessment, Plasma master file, TSE/
BSE evaluation, development and regulatory approval of biologics (Investigational medicinal
products and biosimilars), pre-clinical and clinical development considerations; stability, safety,
advertising, labelling and packing of biologics in EU
12 Hrs
Unit IV
4. Vaccine regulations in India, US and European Union: Clinical evaluation, Marketing
authorisation, Registration or licensing, Quality assessment, Pharmacovigilance, Additional
requirements
12 Hrs
Unit V
5. Blood and Blood Products Regulations in India, US and European Union: Regulatory
Requirements of Blood and/or Its Components Including Blood Products, Label Requirements,
ISBT (International Society of Blood Transfusion) and IHN (International Haemovigilence
Network)
12 Hrs
REFERENCES
1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics,
Douglas J. Pisano , David S. Mantus ; Informa ,2008
2. Biological Drug Products: Development and Strategies; Wei Wang , Manmohan Singh ; wiley,
2013
3. Development of Vaccines: From Discovery to Clinical Testing; Manmohan Singh , Indresh K.
Srivastava ;Wiley, 2011
4. www.who.int/biologicals/en
5. www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
6. www.ihn-org.com
7. www.isbtweb.org
8. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in
India
9. www.cdsco.nic.in
10. www.ema.europa.eu › scientific guidelines › Biologicals
11. www.fda.gov/biologicsbloodVaccines/GuidanceCompliance Regulatory Information
(Biologics)
INTERNATIONAL PHARMACEUTICAL REGULATIONS – II (DRA 203T)

Scope
This course is designed to impart fundamental knowledge on Regulatory Requirements for
registration of drugs, medical devices and post approval requirements in WHO and emerging
market (rest of world countries) like CIS,GCC, LATAM, ASIAN and African region.
Objectives
 Know the regulatory Requirements for drug and medical device registration in emerging
market;
 Understand the registration requirements of emerging market by comparison; and
 Prepare dossiers for the registration of the products in emerging market.
THEORY 60 HOURS
1. Emerging Market: Introduction, Countries covered, Study of the world map,study of various
committees across the globe (ASEAN, APEC, EAC, GCC, PANDRH, SADC)
12Hrs
2. WHO: WHO GMP,Regulatory Requirements for registration of drugs and post approval
requirements in WHO through prequalification programme, Certificate of Pharmaceutical
Product (CoPP) - General and Country Specific (South Africa, Egypt, Algeria and Morocco,
Nigeria, Kenya and Botswana)
12Hrs
3. ASIAN Countries: Introduction to ACTD, Regulatory Requirements for registration of drugs
and post approval requirements in China and South Korea & Association of Southeast Asian
Nations (ASEAN) Region i.e. Vietnam, Malaysia, Philippines, Singapore and Thailand.
12Hrs
4. CIS (Commonwealth Independent States): Regulatory pre-requisites related to Marketing
authorization requirements for drugs and post approval requirements in CIS countries i.e. Russia,
Kazakhstan and Ukraine
12Hrs
5. GCC (Gulf Cooperation Council) for Arab states: Regulatory pre-requisites related to
Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
and UAE
12Hrs
REFERENCES
1.http://www.who.int/medicines/areas/quality_safety/regulation_legislation/
ListMRAWebsites.pdf
2. Roadmap to an ASEAN economic community Edited by Denis Hew. ISEAS Publications,
Singapore 2005, ISBN981-230-347-2
3. ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005, ISBN 978-981-230-750-
7
4. Building a Future With Brics: The Next Decade for Offshoring, Mark Kobayashi-Hillary,
Springer
5. Outsourcing to India: The Offshore Advantage, Mark Kobayashi-Hillary, Springer Trade
performance and Regional Integration of the CIS Countries, Lev Freinkman,
6. The world Bank, Washington, DC, ISBN: 0-8212-5896-0
7. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World By Frederick M.
Abbott, Graham Dukes, Maurice Nelson Graham Dukes 139
8. The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by Linda Low and
Lorraine Carlos Salazar (Nov 22, 2010)
9. Doing Business in the Asean Countries, Balbir Bhasin, Business Expert Press ISBN:13:978-1-
60649-108-9
10. Realizing the ASEAN Economic Community: A Comprehensive Assessment, Michael G
Plummer (Editor), Chia Siow Yue (Editor), Instute of South east asian studies, Singapore
MEDICAL DEVICE REGULATIONS (DRA 204T)

Scope:
This course is designed to impart the fundamental knowledge on the medical devices and in vitro
diagnostics, basis of classification and product life cycle of medical devices, regulatory
requirements for approval of medical devices in regulated countries like US, EU and ASEAN
countries along with WHO regulations. It prepares the students to learn in detail on the
harmonization initiatives, quality and ethical considerations, regulatory and documentation
requirements for marketing medical devices in regulated countries.
Objectives:
Upon completion of the course, the student shall be able to know
 basics of medical devices, process of development, ethical and quality considerations
 harmonization initiatives for approval and marketing medical devices
 regulatory approval process for medical devices in US, EU and Asia
 clinical aspects of medical devices
THEORY 60 Hours
Unit-I
12 Hours
Medical Devices: Introduction, differentiating medical devices from IVDs and Combination
Products, History of Medical Device Regulation, Product Lifecycle of Medical Devices,
Classification of Medical Devices.
IMDRF/GHTF: Introduction, Organizational Structure, Purpose and Functions, Regulatory
Guidelines, Working Groups, Summary Technical Document (STED), Global Medical Device
Nomenclature (GMDN).
Unit-II
12 Hours
Ethics: Clinical Investigation of Medical Devices, Clinical Investigation Plan for Medical
Devices, Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011)
Quality: Quality System Regulations of Medical Devices: ISO 13485, Quality Risk
Management of Medical Devices: ISO 14971, Validation and Verification of Medical device,
Adverse Event Reporting of Medical device
Unit-III
12 Hours
USA: Introduction, Classification, Regulatory approval process for Medical Devices (510k)
Premarket Notification, Pre-Market Approval (PMA), Investigational Device Exemption (IDE)
and In vitro Diagnostics, Quality System Requirements 21 CFR Part 820, Labeling requirements
21 CFR Part 801, Post marketing surveillance of MD and Unique Device Identification (UDI).
Basics of In vitro diagnostics, classification and approval process.
Unit-IV
12 Hours
European Union: Introduction, Classification, Regulatory approval process for Medical Devices
(Medical Device Directive, Active Implantable Medical Device Directive) and In vitro
Diagnostics (In Vitro Diagnostics Directive), CE certification process. Basics of In vitro
diagnostics, classification and approval process.
Unit-V
12 Hours
Medical Device Regulations in World Health Organization (WHO): Registration Procedures,
Quality System requirements and Regulatory requirements Asia: Clinical Trial Regulations
specific for Medical Devices, Registration Procedures, Quality System requirements and
Regulatory requirements for Japan, India and China
REFERENCES:
1. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics by
Douglas J. Pisano, David Mantus.
2. Medical Device Development: A Regulatory Overview by Jonathan S. Kahan
3. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John
J. Tobin and Gary Walsh
4. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics by Carmen
Medina
PHARMACEUTICAL REGULATORY AFFAIRS PRACTICAL-II (DRA 205P)

Number of Practicals based on above mentioned Theory.
M. PHARM. INDUSTRIAL PHARMACY
SEMESTER-1

Scope
characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR,
HPLC, GC etc.
Objectives
THEORY 60 HOURS
1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-
Visible spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible
spectroscopy.
Dispersive and Fourier - Transform IR Spectrometer, Factors affecting vibrational frequencies
and Applications of IR spectroscopy
Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence, Quenchers,
Instrumentation and Applications of fluorescence spectrophotometer.
Flame emission spectroscopy and Atomic absorption spectroscopy: Principle,
Instrumentation, Interferences and Applications.
12 Hrs
2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation,
Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical
shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear
magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR. Applications
of NMR spectroscopy.
12 Hrs
3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types
of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI
Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions,
Isotopic peaks and Applications of Mass spectroscopy
12 Hrs
4 Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors
affecting resolution and applications of the following:
a) Paper chromatography b) Thin Layer chromatography c) Ion exchange chromatography d)
Column chromatography e) Gas chromatography f) High Performance Liquid chromatography g)
Affinity chromatography
12 Hrs
5 Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation
and applications of the following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d) Zone
electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing
X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s law, Rotating
crystal technique, X ray powder technique, Types of crystals and applications of X-ray
diffraction.
12 Hrs
REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition, John
Wiley & Sons, 2004.
5th edition, Eastern press, Bangalore, 1998.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS
7. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel
Dekker Series
PHARMACEUTICAL FORMULATION DEVELOPMENT (MIP101T)

Scope
This course is designed to impart knowledge and skills necessary to train the students on par with
the routine of Industrial activities in R&D and F&D
Objectives
- The scheduled activities in a Pharmaceutical firm.
- The pre formulation studies of pilot batches of pharmaceutical industry.
- The significance of dissolution and product stability
THEORY 60Hrs
12 Hrs
1. Preformulation Studies: Molecular optimization of APIs (drug substances), crystal
morphology and variations, powder flow, structure modification, drugexcipient compatibility
studies, methods of determination.
12 Hrs
2. Formulation Additives: Study of different formulation additivies, factors influencing their
incorporation, role of formulation development and processing, new developments in excipient
science, determination methods, drug excipient interactions. Design of experiments – factorial
design for product and process development.
12 Hrs
3. Solubility: Importance, experimental determination, phase-solubility analysis, pHsolubility
profile, solubility techniques to improve solubility and utilization of analytical methods –
cosolvency, salt formation, complexation, solid dispersion, micellar solubilization and
hydrotropy.
12 Hrs
4. Dissolution: Theories, mechanisms of dissolution, in-vitro dissolution testing models – sink
and non-sink. Factors influencing dissolution and intrinsic dissolution studies. Dissolution test
apparatus – designs, dissolution testing for conventional and controlled release products. Data
handling and correction factor. Biorelevent media, in-vitro and in-vivo correlations, levels of
correlations.
12 Hrs
5. Product Stability: Degradation kinetics, mechanisms, stability testing of drugs and
pharmaceuticals, factors influencing-media effects and pH effects, accelerated stability studies,
interpretation of kinetic data (API & tablets). Solid state stability and shelf life assignment.
Stability protocols, reports and ICH guidelines.
REFERENCES:
1. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy, 3 rd
ed., Varghese Publishers, Mumbai 1991.
2. Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5 th ed., B.I. Publications
Pvt. Ltd, Noida, 2006.
3. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms: tablets Vol. I-III, 2nd
ed., CBS Publishers & distributors, New Delhi, 2005.
4. Conners KA. A Text book of pharmaceutical analysi Wells JI. Pharmaceutical preformulation:
The physicochemical properties of drug substances. Ellis Horwood Ltd., England, 1998.
5. Yalkowsky SH. Techniques of solubilization of drugs. Vol-12. Marcel Dekker Inc., . New
York, 1981
6. Dressman J, Kramer J. Pharmaceutical dissolution testing. Saurah printer pvt. Ltd., New
Delhi,2005.
7. Sethi PD. Quantitative analysis of drugs in pharmaceutical formulations, 3 rd ed., CBS
publications, New Delhi, 2008.
8. Carstensen JT, Rhodes CT. Drug stability principles and practices, 3 rd ed., CBS Publishers &
distributors, New Delhi, 2005.
9. Yoshioka S, Stella VJ. Stability of drugs and dosage forms, Springer (India) Pvt. Ltd., New
Delhi, 2006.
10. Banker GS, Rhodes CT. Modern Pharmaceutics, 4 th ed., Marcel Dekker Inc, New York,
2005.
11. W. Grimm - Stability testing of drug products.
12. Mazzo DJ. International stability testing. Eastern Press Pvt. Ltd., Bangalore, 1999.
13. Beckett AH, Stenlake JB. Practical pharmaceutical chemistry, Part I & II., 4 th ed., CBS
Publishers & distributors, New Delhi, 2004.
14. Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
15. British Pharmacopoeia. British Pharmacopoeia Commission Office, London, 2008.
16. United States Pharmacopoeia. United States Pharmacopeial Convention, Inc, USA, 2003.
CUSTOMIZED DRUG DELIVERY SYSTEMS (MIP102T)

Scope
This course is designed to impart knowledge and skills necessary to train the students in the area
of customized drug delivery systems.
Objective
 The need, concept, design and evaluation of various customized, sustained and controlled
release dosage forms.
 To formulate and evaluate various customized/novel drug delivery systems
THEORY 60Hrs
12 Hrs
1. Concept & Models for NDDS: Classification of rate controlled drug delivery systems (DDS),
rate programmed release, activation modulated & feedback regulated DDS, effect of system
parameters in controlled drug delivery, computation of desired release rate and dose for
controlled release DDS, pharmacokinetic design for DDS – intermittent, zero order & first order
release.
Carriers for Drug Delivery: Polymers / co-polymers-introduction, classification,
characterization, polymerization techniques, application in CDDS / NDDS, biodegradable &
natural polymers.
12 Hrs
2. Study of Various DDS: Concepts, design, formulation & evaluation of controlled release oral
DDS, Mucoadhesive DDS (buccal, nasal, pulmonary) Pulsatile, colon specific, liquid sustained
release systems.
12 Hrs
3. Transdermal Drug Delivery Systems: Theory, design, formulation & evaluation including
iontophoresis and other latest developments in skin delivery systems.
Sub Micron Cosmeceuticals: Biology, formulation science and evaluation of various cosmetics
for skin, hair, nail, oral cavity, eye etc and it’s regulatory aspects.
12 Hrs
4. Targeted Drug Delivery Systems: Importance, concept, biological process and events
involved in drug targeting, design, formulation & evaluation, methods in drug targeting –
nanoparticles, liposomes, niosomes, pharmacosomes, resealed erythorocytes, microspheres,
magnetic microspheres. Specialized pharmaceutical emulsions – multiple emulsions, micro-
emulsions.
Protein / Peptide Drug Delivery Systems: Concepts, delivery techniques, formulation, stability
testing, causes of protein destabilization, stability and destabilization.
Biotechnology in Drug Delivery Systems: Brief review of major are as recombinant DNA
technology, monoclonal antibodies, gene therapy.
12 Hrs
5. Dosage Forms for Personalized Medicine: Introduction, Definition, Pharmacogenetics,
Categories of Patients for Personalized Medicines: Customized drug delivery systems,
Bioelectronic Medicines, 3D printing of pharmaceuticals, Telepharmacy.
REFERENCES:
1. Novel Drug Delivery System, Y.W. Chein, Vol 50, Marcel Dekker, NY.
2. Controlled Drug Delivery Systems, Robinson, Vol 29, Marcel Dekker, NY.
3. Transdermal Controlled Systemic Medications, YW Chein, Vol 31, Marcel Dekker, NY.
4. Bioadhesive DDS, E. Mathiowitz, Vol 98, Marcel Dekker, NY.
5. Nasal System Drug Delivery, K.S.E. Su, Vol 39, Marcel Dekker, NY.
6. Drug Delivery Devices, Vol 32, P Tyle Marcel Dekker, NY.
7. Polymers for Controlled Drug Delivery, P.J. Tarcha, CRC Press.
8. Pharmaceutical Biotechnology, Vyas, CBS, Delhi.
9. Biotechnology of Industrial Antibiotics, E.J. Vandamme, Marcel Dekker, NY.
10. Protein Formulation & Delivery, E.J. McNally, Vol 99, Marcel Dekker, NY.
11. Drug Targeting, M.H. Rubinstein, John Wiley, NY.
DRUG REGULATIONS AND INTELECTUAL PROPERTY RIGHTS (MIP103T)

Scope
This course is designed to impart knowledge and skills necessary to train the students to be on
par with the routine of Industrial activities in drug regulatory affairs
Objectives
 Assist in Regulatory Audit process.
 Establish regulatory guidelines for drug and drug products
 The Regulatory requirements for contract research organization
THEORY 60Hrs
12 Hrs
1. Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to
be patentable, Introduction to patent search. Parts of patents. Filling of patents. The essential
elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in
Patent.
12 Hrs
2. Role of GATT, TRIPS, and WIPO.
12 Hrs
3. Brief introduction to Trademark protection and WHO Patents. IPR’s and its types, Major
bodies regulating Indian Pharmaceutical sector,
12 Hrs
4. Brief introduction to CDSCO. WHO, USFDA, EMEA, TGA, MHRA, MCC, ANVISA
12 Hrs
5. Regulatory requirements for contract research organization. Regulations for Biosimilars.
REFERENCES:
1. Pharmaceutical Process Validation: By Fra R. Berry and Robert A. Nash, Vol 57, 2nd Edition
2. Applied Production and Operation Management By Evans, Anderson and Williams
3. GMP for pharmaceuticals Material Management by K.K. Ahuja Published by CBS publishers
4. ISO 9000-Norms and explanations 148
5. GMP for pharmaceuticals- Willing S.H. Marcel and Dekker
INDUSTRIAL PHARMACY PRACTICAL-I (MIP104P)
1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer

spectrophotometry
7. Effect of surfactants on the solubility of drugs.
8. Effect of pH on the solubility of drugs.
9. Dissolution methods of transdermal drug delivery systems.
10. Stability testing of solution and solid dosage forms for photo degradation..
11. Stability studies of drugs in dosage forms at 25 oC, 60% RH and 40oC, 75% RH.
12. Compatibility evaluation of drugs and excipients.
13. Preparation and evaluation of different polymeric membranes.
14. Formulation and evaluation of sustained release oral matrix tablet.
15. Formulation and evaluation of sustained release oral reservoir system.
16. Formulation and evaluation of microspheres / microcapsules.
17. Formulation and evaluation of transdermal films.
18. Design and evaluation of face wash, body- wash, creams, lotions, shampoo, toothpaste,
lipstick.
SEMESTER-II
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS (MIP201T)

Scope
This course is designed to impart knowledge and skills necessary for dose calculations, dose
adjustments and to apply Biopharmaceutics theories in practical problem solving.
Objectives
At completion of this course it is expected that students will be able to understand–
 The basic concepts in Biopharmaceutics and pharmacokinetics.
 The use of raw data and derive the pharmacokinetic models and parameters the best describe
the process of drug absorption, distribution, metabolism and elimination.
 To critically evaluate Biopharmaceutics studies involving drug product equivalency.
 To design and evaluate dosage regimens of the drugs using pharmacokinetic and
biopharmaceutic parameters.
THEORY 60Hrs
12Hrs
1. Drug Absorption From The Gastrointestinal Tract: Gastrointestinal tract, Mechanism of
drug absorption, Factors affecting passive drug absorption, pH– partition theory of drug
absorption. Factors affecting drug absorption: physicochemical factors: Dissolution rate,
Dissolution process, Noyes– Whitney equation and drug dissolution, Factors affecting the
dissolution rate. Gastrointestinal absorption: role of the dosage form: Solution (elixir, syrup and
solution) as a dosage form ,Suspension as a dosage form, Capsule as a dosage form, Tablet as a
dosage form ,Dissolution methods ,Formulation and processing factors, Correlation of in vivo
data with in vitro dissolution data. Transport model: Permeability-Solubility-Charge State and
the pH Partition Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH Microclimate
Intracellular pH Environment, Tight-Junction Complex, Structure of Octanol, Biopharmaceutics
Classification System. Solubility: Experimental methods. Permeability: In-vitro, in-situ and In-
vivo methods.
12Hrs
2. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product
Performance: Introduction, Biopharmaceutic Factors Affecting Drug Bioavailability, Rate-
Limiting Steps in Drug Absorption, Physicochemical Nature of the Drug Formulation Factors
Affecting Drug Product Performance, Drug Product Performance, In Vitro: Dissolution and Drug
Release Testing, Compendial Methods of Dissolution, Alternative Methods of Dissolution
Testing, Meeting Dissolution Requirements, Problems of Variable Control in Dissolution Testing
Performance of Drug Products: In Vitro–In Vivo Correlation, Dissolution Profile Comparisons,
Drug Product Stability, Considerations in the Design of a Drug Product, Drug Product
Considerations.
12Hrs
3. Pharmacokinetics: Basic considerations, Pharmacokinetic models, Compartment modeling:
One compartment model- IV bolus, IV infusion, Extra-vascular; Multi Compartment model:
Two compartment - model in brief, Non-Linear Pharmacokinetics: Cause of non-linearity,
Michaelis – Menten equation, Estimation Kmax and Vmax. Drug interactions: Introduction, The
effect of protein-binding interactions, The effect of tissue-binding interactions, Cytochrome
P450-based drug interactions, Drug interactions linked to transporters.
12Hrs
4. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence: Drug Product
Performance, Purpose of Bioavailability Studies, Relative and Absolute Availability, , Methods
for Assessing Bioavailability, Bioequivalence Studies, Design and Evaluation of Bioequivalence
Studies, Study Designs, Crossover Study Designs, Evaluation of the Data, Bioequivalence
Example, Study Submission and Drug Review Process, The Biopharmaceutics Classification
System, Generic Biologics (Biosimilar Drug Products),Clinical Significance of Bioequivalence
Studies, Special Concerns in Bioavailability and Bioequivalence Studies, Generic Substitution.
12Hrs
5. Application of Pharmacokinetics: Modified-Release Drug Products, Targeted Drug Delivery
Systems and Biotechnological Products. Relationship between Pharmacokinetics and
Pharmacodynamics: Generation of a pharmacokinetic– pharmacodynamic (PKPD) equation,
Pharmacokinetic and pharmacodynamic, drug interactions. Pharmacokinetics and
pharmacodynamics of biotechnology drugs: Introduction, Proteins and peptides, Monoclonal
antibodies, Oligonucleotides, Vaccines (immunotherapy),Gene therapies.
REFERENCES:
1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4 th edition,Philadelphia,
Lea and Febiger, 1991
2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.
Jaiswal., Vallab Prakashan, Pitampura, Delhi
3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2nd edition,
Connecticut Appleton Century Crofts, 1985
4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,Prism
Book
5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc., New York,
1982
6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Lea and
Febiger, Philadelphia, 1970
7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm Rowland and
Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995
8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack Publishing Company,
Pennsylvania 1989
9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition, revised and
expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,1987.
10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and M.Pemarowski,
1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.
11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan,
Marcel Dekker Inc, New York, 1996.
12. Basic Pharmacokinetics,1 st edition, Sunil S Jambhekar and Philip J Breen,pharmaceutical
press, RPS Publishing,2009.
13. Absorption and Drug Development- Solubility, Permeability, and Charge State, Alex Avdeef,
John Wiley & Sons, Inc,2003.
SCALE UP AND TECHNOLOGY TRANSFER (MIP202T)
Scope
scale up, technology transfer process and industrial safety issues.
Objectives:
 Manage the scale up process in pharmaceutical industry.
 Assist in technology transfer.
 To establish safety guidelines, which prevent industrial hazards.
THEORY 60Hrs
12Hrs
1. Pilot plant design: Basic requirements for design, facility, equipment selection, for tablets,
capsules, liquid orals, parentrals and semisolid preparations.
Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale, process
scale up for tablets, capsules, liquid orals, semisolids, parentrals, NDDS products – stress on
formula, equipments, product uniformity, stability, raw materials, physical layout, input, in-
process and finished product specifications, problems encountered during transfer of technology.
12Hrs
2. Validation: General concepts, types, procedures & protocols, documentation, VMF.
Analytical method validation, cleaning validation and vender qualification.
12Hrs
3. Equipment Qualification: Importance, IQ, OQ, PQ for equipments – autoclave, DHS,
membrane filter, rapid mixer granulator, cone blender, FBD, tablet compression machine, liquid
filling and sealing machine.
12Hrs
4. Process validation: importance, validation of mixing, granulation, drying, compression, tablet
coating, liquid filling and sealing, sterilization, water process systems, environmental control.
12Hrs
6. Industrial safety: Hazards – fire, mechanical, electrical, chemical and pharmaceutical,
Monitoring & prevention systems, industrial effluent testing & treatment. Control of
environmental pollution.
REFERENCES:
1. Pharmaceutical process validation, JR Berry, Nash, Vol 57, Marcel Dekker, NY.
2. Pharmaceutical Production facilities, design and applications, by GC Cole, Taylor and Francis.
3. Pharmaceutical project management, T.Kennedy, Vol 86, Marcel Dekker, NY.
4. The theory & Practice of Industrial Pharmacy, L.Lachman, H.A.Lieberman, Varghese Publ.
Bombay.
5. Tablet machine instruments in pharmaceuticals, PR Watt, John Wiloy.
6. Pharmaceutical dosage forms, Tablets, Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker,
NY.
7. Pharmaceutical dosage forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker,
NY.
8. Dispersed system Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
9. Subrahmanyam, CVS, Pharmaceutical production and Management,2007,Vallabh
Prakashan,Dehli.
PHARMACEUTICAL PRODUCTION TECHNOLOGY (MIP203T)

Scope
par with the routine of Industrial activities in Production
Objectives
At completion of this course it is expected that students will be able to understand–
 Handle the scheduled activities in a Pharmaceutical firm.
 Manage the production of large batches of pharmaceutical formulations.
THEORY 60Hrs
12Hrs
1. Improved Tablet Production: Tablet production process, unit operation improvements,
granulation and pelletization equipments, continuous and batch mixing, rapid mixing
granulators, rota granulators, speronizers and marumerisers, and other specialized granulation
and drying equipments. Problems encountered.
Coating Technology: Process, equipments, particle coating, fluidized bed coating, application
techniques. Problems encountered.
12Hrs
2. Parenteral Production: Area planning & environmental control, wall and floor treatment,
fixtures and machineries, change rooms, personnel flow, utilities & utilities equipment location,
engineering and maintenance.
12Hrs
3. Lyophilization Technology: Principles, process, freeze-drying equipments.
12Hrs
4. Capsule Production: Production process, improved capsule manufacturing and filling
machines for hard and soft gelatin capsules. Layout and problems encountered.
Disperse Systems Production: Production processes, applications of mixers, mills, disperse
equipments including fine solids dispersion, problems encountered.
Packaging Technology: Types of packaging materials, machinery, labeling, package printin for
different dosage forms.
12Hrs
5. Air Handling Systems: Study of AHUs, humidity & temperature control, air filtration
systems, dust collectors.
Water Treatment Process: Techniques and maintenance – RO, DM, ultra – filtration, WFI.
REFERENCES:
1. The theory & Practice of Industrial Pharmacy, L. Lachman, Varghese Publ, Bombay.
2. Modern Pharmaceutics by Banker, Vol 72, Marcel Dekker, NY.
3. Pharmaceutical Dosage Forms, Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
4. Pharmaceutical Dosage Forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker,
NY.
5. Pharmaceutical Production Facilities, design and applications, by G.C. Cole, Taylor and
Francis.
6. Dispersed System Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
7. Product design and testing of polymeric materials by N.P. Chezerisionoff.
8. Pharmaceutical Project Management, T.Kennedy, Vol 86, Marcel Dekker, NY.
9. Packaging Pharmaceutical and Health Care, H.Lockhard.
10. Quality Control of Packaging Materials in Pharmaceutical Industy, .Kharburn, Marcel
Dekker, NY.
11. Freeze drying / Lyophilization of Pharmaceuticals & Biological Products, L. Ray, Vol 96,
Marcel Dekker, NY.
12. Tablet Machine instrumentation in pharmaceuticals, PR Watt, Ellis Horwoods, UK. 156
ENTREPRENEURSHIP MANAGEMENT (MIP204T)

Scope
This course is designed to impart knowledge and skills necessary to train the students on
entrepreneurship management.
Objectives:
 The Role of enterprise in national and global economy
 Dynamics of motivation and concepts of entrepreneurship
 Demands and challenges of Growth Strategies And Networking
THEORY 60Hrs
12Hrs
1. Conceptual Frame Work
Concept need and process in entrepreneurship development. Role of enterprise in national and
global economy.Types of enterprise – Merits and Demerits. Government policies and schemes
for enterprise development. Institutional support in enterprise development and management
12Hrs
2. Entrepreneur
Entrepreneurial motivation – dynamics of motivation. Entrepreneurial competency– Concepts.
Developing Entrepreneurial competencies - requirements and understanding the process of
entrepreneurship development, self awareness, interpersonal skills, creativity, assertiveness,
achievement, factors affecting entrepreneur role.
12Hrs
3. Launching And Organising An Enterprise
Environment scanning – Information, sources, schemes of assistance, problems. Enterprise
selection, market assessment, enterprise feasibility study, SWOT Analysis. Resource
mobilisation - finance, technology, raw material, site and manpower. Costing and marketing
management and quality control. Feedback, monitoring and evaluation.
12Hrs
4. Growth Strategies And Networking
Performance appraisal and assessment. Profitability and control measures, demands and
challenges. Need for diversification. Future Growth – Techniques of expansion and
diversification, vision strategies. Concept and dynamics. Methods, Joint venture, co-ordination
and feasibility study.
12Hrs
5. Preparing Project Proposal To Start On New Enterprise
Project work – Feasibility report; Planning, resource mobilisation and implementation.
REFERENCES:
1. Akhauri, M.M.P.(1990): Entrepreneurship for Women in India, NIESBUD, New Delhi.
2. Hisrich, R.D & Brush, C.G.(1996) The Women Entrepreneurs, D.C. Health & Co., Toranto.
3. Hisrich, R.D. and Peters, M.P. (1995): Entrepreneurship – Starting, Developing and Managing
a New Enterprise, Richard D., Inwin, INC, USA.
4. Meredith, G.G. etal (1982): Practice of Entrepreneurship, ILO, Geneva.
5. Patel, V.C.(1987): Women Entrepreneurship – Developing New Entrepreneurs, Ahmedabad
EDII.
INDUSTRIAL PHARMACY PRACTICAL-II (MIP205P)
Number of Practicals based on above mentioned Theory.

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SYLLABUS - M. PHARM COURSES w.e.f.

M. PHARM. PHARMACEUTICAL CHEMISTRY (MPC)

ADVANCED ORGANIC CHEMISTRY-1 (MPC101T)

ADVANCED MEDICINAL CHEMISTRY (MPC102T)

PHARMACEUTICAL CHEMISTRY PRACTICAL-I (MPC104P)

ADVANCED SPECTRAL ANALYSIS (MPC201T)

ADVANCED ORGANIC CHEMISTRY–II (MPC202T)

COMPUTER AIDED DRUG DESIGN (MPC203T)

PHARMACEUTICAL CHEMISTRY PRACTICAL-II (MPC205P)

1. Synthesis of organic compounds by adapting different approaches involving (3 experiments)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MPA101T)

ADVANCED PHARMACOGNOSY-1 (MPG101T)

INDUSTRIAL HERBAL DRUG TECHNOLOGY (MPG103T)

PHARMACOGNOSY PRACTICAL-I (MPGI04P)

1. Analysis of pharmacopoeial compounds of natural origin and their formulations by UV Vis

MEDICINAL PLANT BIOTECHNOLOGY (MPG201T)

ADVANCED PHARMACOGNOSY-II (MPG202T)

INDIAN SYSTEMS OF MEDICINE (MPG203T)

1. Isolation of nucleic acid from cauliflower heads

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MPA101T)

ADVANCED PHARMACOLOGY-I (MPL101T)

PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-I

CELLULAR AND MOLECULAR PHARMACOLOGY (MPL103T)

PHARMACOLOGY PRACTICAL-I (MPL104P)

1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer

ADVANCED PHARMACOLOGY-II (MPL201T)

Recent Advances in Treatment: 08 Hrs

PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

PRINCIPLES OF DRUG DISCOVERY (MPL203T)

CLINICAL RESEARCH AND PHARMACOVIGILANCE (MPL204T)

PHARMACOLOGY PRACTICAL-II (MPL205P)

1. To record the DRC of agonist using suitable isolated tissues preparation.

GOOD PHARMACEUTICAL PRACTICES (DRA 101T)

PHARMACEUTICAL REGULATIONS IN INDIA (DRA 102T)

INTERNATIONAL PHARMACEUTICAL REGULATIONS-I (DRA103T)

CLINICAL RESEARCH REGULATIONS (DRA 104T)

PHARMACEUTICAL REGULATORY AFFAIRS PRACTICAL-I (MRA105P)

1. Case studies (4 Nos.) of each of Good Pharmaceutical Practices.

DOCUMENTATION AND REGULATORY WRITING (DRA 201T)

INTERNATIONAL PHARMACEUTICAL REGULATIONS – II (DRA 203T)

MEDICAL DEVICE REGULATIONS (DRA 204T)

PHARMACEUTICAL REGULATORY AFFAIRS PRACTICAL-II (DRA 205P)

M. PHARM. INDUSTRIAL PHARMACY

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MPA101T)

PHARMACEUTICAL FORMULATION DEVELOPMENT (MIP101T)

CUSTOMIZED DRUG DELIVERY SYSTEMS (MIP102T)

DRUG REGULATIONS AND INTELECTUAL PROPERTY RIGHTS (MIP103T)

INDUSTRIAL PHARMACY PRACTICAL-I (MIP104P)

1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer

ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS (MIP201T)

PHARMACEUTICAL PRODUCTION TECHNOLOGY (MIP203T)

ENTREPRENEURSHIP MANAGEMENT (MIP204T)

INDUSTRIAL PHARMACY PRACTICAL-II (MIP205P)

Number of Practicals based on above mentioned Theory.

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