International Stability Testing

David J. Mazzo

• Publisher: CRC Press
• Year: 2020
• Print ISBN: 9781574910780
• eBook ISBN: 9781000161663
• Topic: Business
• Subtopic: Pharmaceutical, Biotechnology & Healthcare Industry
• Index: Business

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.

Table of contents

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