International Stability Testing
eBook - ePub

International Stability Testing

  1. 352 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

International Stability Testing

Book details
Table of contents
Citations

About This Book

In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

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Yes, you can access International Stability Testing by David J. Mazzo in PDF and/or ePUB format, as well as other popular books in Betriebswirtschaft & Pharma-, Biotechnologie- & Gesundheitsindustrie. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2020
ISBN
9781000161663
Edition
1
Topic
Betriebswirtschaft
Subtopic
Pharma-, Biotechnologie- & Gesundheitsindustrie

Table of contents

  1. Cover
  2. Title Page
  3. Copyright Page
  4. Table of Contents
  5. Foreword
  6. 1. The ICH Stability Guideline
  7. 2. Photostability Testing
  8. 3. The ICH Stability Guideline for Biological and Biotechnological Products
  9. 4. Stress Testing Program: Drug Substance Characterization Studies
  10. 5. Statistical and Regulatory Aspects of Drug Stability Studies: An FDA Perspective
  11. 6. Matrixing and Bracketing Designs for Stability Studies: An Overview from the European Perspective
  12. 7. Assessment of Preservative Activity During Stability Studies
  13. 8. Drug Substance Solid-State Characterization and Stability
  14. 9. Variations and Changes in Europe: Stability Requirements
  15. 10. Postapproval FDA Stability Requirements
  16. 11. Current Application in Japan of the ICH Stability Guidelines: Does Japanese Registration Require More Than Others Do?
  17. 12. Stability Testing for Australia
  18. 13. The WHO Stability Guideline
  19. 14. Stability Testing Considerations for Some Non-ICH Areas
  20. Index