International Stability Testing

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.

List of contents

ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.

About the author

David J. Mazzo

Product details

• Assisted by: David J. Mazzo (Editor), Mazzo David J. (Editor)
• Publisher: Taylor and Francis
• Languages: English
• Product format: Hardback
• Released: 31.08.1998
• EAN: 9781574910780
• ISBN: 978-1-57491-078-0
• No. of pages: 350
• Weight: 810 g
• Subjects: Natural sciences, medicine, IT, technology > Medicine > General; Social sciences, law, business > Business > Miscellaneous; Medical research, MEDICAL / Pharmacy, MEDICAL / Pharmacology, MEDICAL / Research, Pharmacology, Pharmacy / dispensing