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DEO PHARMACOKINETICS
1. Why creatinine is used to measure renal failure.

B’se renal failure is estimated by GFR and GRF is measured by using a substance that
is eliminated by filtration only and the substance is creatinine which is neither
reabsorbed nor secreted therefore observed GFR is compared to the normal
standard range.
2. Mention reaction kinetics in pharmacokinetics.
a. Zero order e.g. aspirin, tolbutamide, phenytoin, salicylate and theophylline
ethanol,
b. First order e.g. paracetamol, aminoglycosides etc
3. What is AUC and its importance.
a. AUC is the definite integral in a plot of drug conc in blood plasma against time
and it reflect the actual body exposed to drug after administration of dose of
a drug.
b. The area under the drug concentration-time curve (AUC) is used as a measure
of the total amount of unaltered drug that reaches the systemic circulation.
4. What are the tests used to measure hepatic drug metabolism? (Hints there is no
single laboratory test that can be used to assess liver function)
a. The most common way to estimate the ability of the liver to metabolize
drug is to determine the Child-Pugh score for a patient. (best)
b. Sorbitol with high intrinsic clearance can reflect liver blood flow
c. Trimethadione a low-extraction drug has been used to measure liver enzyme
capacity
d. Antipyrene and Aminopyrene tests
5. laboratory test based on child pugh scores. (STAPH)
a. Serum albumin
b. Total bilirubin
c. Ascites
d. Prothrombin time
e. Hepatic encephalopathy
6. Examples of drug that should be adjusted from heart failure patients. (LMoT)
a. Lignocaine
b. Morphine
c. Tricyclic antidepressant
d. Propranolol
e. Levodopa
f. Ca2+ channel blockers e.g. verapamil
g. Chlorpromazine/haloperidol
7. How will you adjust drug in kidney failure patients?
Actually, method of prescribe drugs depend on
a. Route of administration
b. Available dose
Oral administration; - give usual dose and prolong dose interval

Parenteral administration; - simultaneously modify both dose and dose interval to attain the
same Cmax and Cmin
8. Types of protein involved on drug bounding.
a. Serum albumin
b. Alpha acid glycoprotein
c. Lipoprotein
d. Glycoprotein transferrin
e. α, β and γ globulin
9. Examples of drugs following zero order reaction kinetics.
Aspirin, tolbutamide, phenytoin, salicylate and theophylline, ethanol etc.
Kimaro GMP
10. What is gmp

GMP is that part of quality assurance which ensures that products are consistently
produced and controlled to the quality standards appropriate to their intended use
and as required by the marketing authorization.
11. Is gmp necessary where there is Q.C laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be
tested into the product afterwards. GMP prevents errors that cannot be eliminated
through quality control of the finished product. Without GMP it is impossible to be
sure that every unit of a medicine is of the same quality as the units of medicine
tested in the laboratory.
12. What is product recall and reason to it?
Product recall is a request from a manufacturer to return a product after the
discovery of safety issues or product defects that might endanger the consumer or
put the seller at risk of legal action.
REASONS
• Serious reports of adverse drug reactions not included in the package insert
• Unexpected frequency of adverse reaction stated in the package insert.
• Incorrect labeling of a product.
• Incorrect product formulation.
• Result of ongoing stability studies.
13. What is cross contamination?
Is an unintentional contamination of starting material, intermediate product or
finished product with another starting material, intermediate product or finished
product.
14. How to control cross contamination?
a. Carrying out production in dedicated and self-contained areas. may be
required for products such as penicillin
b. Using a “closed system” in production providing appropriately designed
airlocks, pressure differentials, and air supply and extraction systems
c. Operations on different products should not be carried out simultaneously
or consecutively (before cleaning) in the same room
d. wearing protective clothing where products or materials are handled
e. using cleaning and decontamination procedures of known effectiveness
f. testing for residues
g. using cleanliness status labels on equipment
15. Mention the key personnel.

a. Head of production
b. Head of quality units
c. Authorised person
16. Shared responsibilities of key persons.
a. Authorization of written procedures and other documents, including
amendments.
b. Monitoring and control of the manufacturing environment
c. Plant hygiene
d. Process validation and calibration of analytical apparatus
e. Training, including the application and principles of QA
f. Approval and monitoring of suppliers of material
g. Approval and monitoring of contract manufacturers
h. Designation and monitoring of storage conditions for materials and products
i. Performance and evaluation of in process controls
j. Retention of records
k. Monitoring of compliance with GMP requirements
l. Inspection, investigation and taking of samples in order to monitor factors
that may affect product quality.
17. How to control rejected, reprocessed, recovered and reworked materials.
a. Rejected materials and products should be clearly marked as such and stored
separately in restricted areas.
b. They should either be returned to the suppliers or, where appropriate,
reprocessed or destroyed in a timely manner.
c. Whatever action is taken should be approved by authorized personnel and
recorded.
d. The reworking or recovery of rejected products should be permitted only if
the quality of the ﬁnal product is not affected.
e. A reworked batch should be given a new batch number.
18. How to handle starting material and intermediate bulk and finished products.
a. The purchase of starting materials should involve staff who have a particular
and thoroughly knowledge of the products and suppliers.
b. Purchasing should be only from approved suppliers.
c. The specifications established by the manufacturer for the starting materials
should be discussed with the suppliers.
d. Intermediate and bulk products should be kept under appropriate condition
e. Finished products should be held in quarantine until their final release, after
which they should be stored as usable stock under conditions established by
the manufacturer
19. Importance of stability testing.
Help to establish expiry dates and shelf-life specifications on the basis of stability
tests related to storage conditions
20. Important information on sample container.
a. The name of the medicines
b. A list of the active ingredients, showing the amount of each present
c. The batch number assigned by the manufacturer
d. The expiry date in an uncorded form
e. Any special storage conditions or handling precautions that may be
necessary
f. directions for use, and warnings and precautions that may be necessary
g. the name and address of the manufacturer or the company or the person
responsible for placing the product on the market
21. Importance of self-inspection.
a. The purpose of self-inspection is to evaluate the manufacturer’s compliance
with GMP in all aspects of production and Quality Control.
b. Should be designed to detect any shortcomings in the implementation of
GMP and to recommend the necessary corrective actions.
FROM JAMBAZI

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DEO PHARMACOKINETICS

1. Why creatinine is used to measure renal failure.

Oral administration; - give usual dose and prolong dose interval

10. What is gmp

15. Mention the key personnel.

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