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Methods for Stability Testing of Pharmaceuticals

  • Book
  • © 2018

Overview

Editors:
  1. Sanjay Bajaj

    1. Select Biosciences India Private Limited, Chandigarh, India

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  2. Saranjit Singh

    1. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, India

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • Features contributions from labs around to globe to ensure thorough coverage of a wide variety of successful stability programs
  • Contains key implementation advice from the experts
  • Provides the kind of practical details necessary for lab implementation

Part of the book series: Methods in Pharmacology and Toxicology (MIPT)

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Table of contents (15 protocols)

  1. Front Matter

    Pages i-xiv
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  2. Regulatory Guidelines on Stability Testing and Trending of Requirements

    • Dilip Kumar Singh, Saranjit Singh, Sanjay Bajaj
    Pages 1-30

  3. The Stability Dossier: Common Deficiencies and Ways to Improve

    • Paul Marshall
    Pages 31-51

  4. In Silico Drug Degradation Prediction

    • Mohammed A. Ali, Rachel Hemingway, Martin A. Ott
    Pages 53-73

  5. Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach

    • Markus Zimmer
    Pages 75-98

  6. A Model Approach for Developing Stability-Indicating Analytical Methods

    • Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, Koen Vanhoutte
    Pages 99-121

  7. Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities

    • Steven Hostyn, Peter Persich, Shalu Jhajra, Koen Vanhoutte
    Pages 123-141

  8. Stability Studies: Facility and Systems

    • Ashish Gogia, Sumathi V. Rao
    Pages 143-174

  9. User Requirements and Implementation of a Risk-Based, Compliant Stability Management System

    • Susan Cleary, Parsa Famili, Pedro Jorge
    Pages 175-193

  10. Stability Considerations in the Life Cycle of Generic Products

    • Sanjay Bajaj, Srinivasan Rajamani, Mona Gogia
    Pages 195-212

  11. Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies

    • Helen Williams
    Pages 213-232

  12. Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life

    • B. V. Suresh Kumar, Priyank Kulshrestha, Sandeep Shiromani
    Pages 233-260

  13. Estimation of Stability Based on Monitoring of Shipment and Storage

    • Manuel Zahn
    Pages 261-292

  14. Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products

    • Kamla Pathak, Satyanarayan Pattnaik
    Pages 293-305

  15. Stability Testing Issues and Test Parameters for Herbal Medicinal Products

    • Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur, Rahul Singh Negi
    Pages 307-333

  16. Stability Testing Considerations for Biologicals and Biotechnology Products

    • Christine P. Chan
    Pages 335-347

  17. Back Matter

    Pages 349-358
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Keywords

About this book

This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. 

Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.

Editors and Affiliations

  • Select Biosciences India Private Limited, Chandigarh, India

    Sanjay Bajaj

  • Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, India

    Saranjit Singh

Bibliographic Information

  • Book Title: Methods for Stability Testing of Pharmaceuticals

  • Editors: Sanjay Bajaj, Saranjit Singh

  • Series Title: Methods in Pharmacology and Toxicology

  • DOI: https://doi.org/10.1007/978-1-4939-7686-7

  • Publisher: Humana New York, NY

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media, LLC, part of Springer Nature 2018

  • Hardcover ISBN: 978-1-4939-7685-0Published: 25 May 2018

  • Softcover ISBN: 978-1-4939-9258-4Published: 25 July 2019

  • eBook ISBN: 978-1-4939-7686-7Published: 25 May 2018

  • Series ISSN: 1557-2153

  • Series E-ISSN: 1940-6053

  • Edition Number: 1

  • Number of Pages: XIV, 358

  • Number of Illustrations: 51 b/w illustrations, 42 illustrations in colour

  • Topics: Pharmacology/Toxicology

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