Scribd Logo
Upload

Welcome to Scribd!

  • 57 views

    Pharmaceutical Process Scale-Up, 3rd Edition: Drug Development and Industrial Pharmacy

    Uploaded by

    rajuvadlakonda

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Pharmaceutical Process Scale-Up, 3rd Edition: Drug Development and Industrial Pharmacy

    Uploaded by

    rajuvadlakonda
    57 views2 pages

    Original Title

    felton2011

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    57 views2 pages

    Pharmaceutical Process Scale-Up, 3rd Edition: Drug Development and Industrial Pharmacy

    Uploaded by

    rajuvadlakonda

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Drug Development and Industrial Pharmacy

    ISSN: 0363-9045 (Print) 1520-5762 (Online) Journal homepage: http://www.tandfonline.com/loi/iddi20

    Pharmaceutical Process Scale-Up, 3rd edition

    Linda A. Felton

    To cite this article: Linda A. Felton (2012) Pharmaceutical Process Scale-Up, 3rd edition, Drug
    Development and Industrial Pharmacy, 38:4, 512-512, DOI: 10.3109/03639045.2011.633523

    To link to this article: https://doi.org/10.3109/03639045.2011.633523

    Published online: 16 Nov 2011.

    Submit your article to this journal

    Article views: 173

    View related articles

    Full Terms & Conditions of access and use can be found at


    http://www.tandfonline.com/action/journalInformation?journalCode=iddi20
    Drug Development and Industrial Pharmacy, 2012; 38(4): 512
    © 2012 Informa Healthcare USA, Inc.
    ISSN 0363-9045 print/ISSN 1520-5762 online
    DOI: 10.3109/03639045.2011.633523

    Book Reviews

    Pharmaceutical Process Scale-Up, 3rd edition perspective. Much of this chapter is focused on model-
    Michael Levin, Editor based process optimization. Risk assessment and
    Informa Healthcare, New York City, 2011 understanding risks during scale-up are discussed in
    Chapter 3. This new chapter provides insight into assess-
    The development of pharmaceutical products generally ing and controlling risk, focusing predominately on API
    begins in a research laboratory where quantities of the manufacturing. Other notable new chapters cover pro-
    active pharmaceutical ingredient (API) are limited and cess validation, scale up of continuous blending, and
    quantities of product needed are small. For commer- virtual scale up of manufacturing processes. The updated
    cial products, however, large quantities of materials are Appendices include internet links for FDA, EU, and ICH
    required and significant problems may be encountered harmonization guidelines.
    during this scale up phase of the drug development pro- As with the previous edition, much of the book is
    cess. The text, Pharmaceutical Process Scale-Up, covers devoted to specific processes, such as powder blend-
    both theoretical and practical aspects of ‘scaling up’ API ing and granulation, roller compaction, extrusion and
    and drug product batch size. This is the third edition of spheronization, tableting, capsule filling, and coating.
    the text, demonstrating the interest in the subject from Semi-solids, liquids, and parenterals are also covered.
    the pharmaceutical industry. As with the previous edi- Overall, the book provides practical approaches for scal-
    tion, the editor has compiled well known engineers and ing up of both drugs and drug products. This book will be
    formulation scientists to author the chapters. valuable to formulation scientists, process engineers, and
    The text begins with a chapter on dimensional analysis anyone else involved in scale up activities. The references
    and scale up in theory as well as industrial application. to PAT, quality by design, and question-based review will
    Simple examples are provided to demonstrate the theo- particularly appeal to validation and quality assurance
    retical fundamentals of dimensional analysis, although personnel.
    mathematically these examples become increasingly
    complex. The next chapter focuses on process scale-up, Linda A. Felton, Ph.D.
    validation, and optimization using process analytical University of New Mexico
    technologies (PAT) and is written from an engineering College of Pharmacy

    512

    You might also like

    pFad - Phonifier reborn

    Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

    Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


    Alternative Proxies:

    Alternative Proxy

    pFad Proxy

    pFad v3 Proxy

    pFad v4 Proxy