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International Stability Testing
Editor(s) :David J. Mazzo

ISBN : 1574910787
Name : International Stability Testing
Price : 2995.00
Editor/s : David J. Mazzo
Type : Reference Book
Pages : 332
Year of Publication : Rpt.2011
Publisher : Taylor & Francis/BSP Books
Binding : Hardback
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About the Book

International Stability Testing, edited by David Mazzo, contains the latest information available about worldwide pharmaceutical stability guidelines and requirements. Recent changes in European

Requirements, the ICH initiatives, the U.S. SUPAC initiative, rnatrixing and bracketing approaches from the FDA cGMP perspective, and stability requirements in Japan. Australia, and WHO guidelines are all explained by 15 leading experts in the field.

Other topics covered include stress programs, stability testing of pharmaceutical preservatives, physical stability, protocols, and statistical approaches. The book also contains practical examples and current guidelines complete with thorough discussions and interpretations.

Chapters

The ICH Stability Guideline / David J. Mazzo

Photo stability Testing / Terry G. Beaumont

The ICH Stability Guideline for Biological and Biotechnological Products / Manfred Haase

Stress Testing Program: Drug Substance Characterization Studies / Elisabeth Pacaud.

Statistical and Regulatory Aspects of Drug Stability Studies: An FDA Perspective / William R. Fair weather and Tase-Yun Daphne Lin

Matrixing and Bracketing Designs for Stability Studies: An Overview from the European Perspective / Per Helboe

Assessment of Preservative Activity During Stability Studies / Norman Hodges

Drug Substance Solid-Stale Characterization and Stability / Ivan Santos

Variations and Changes in Europe: Stability Requirements / Anthony C. Cartwright

Post approval FDA Stability Requirements / Dhiren N. Shah

Current Application in Japan of the ICH Stability Guidelines: Does Japanese Registration Require More Than the Others Do? / Sumie Yoshioka

Stability Testing in Australia / Susan Walters

The WHO Stability Guideline / Sabine Kopp-Kubel and Manuel Zahn

Stability Testing Considerations for Some Non-ICH Areas / Terry G. Beaumont

Pharmaceutical scientists, stability laboratory managers and staff, regulatory professionals, QA/QC managers, and analysts will all find this book to be an invaluable guide and reference.

Contents

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

About the Author

David J. Mazzo is Senior Vice President and Global Head of Pharmaceutical Development for Hoechst Marion Roussel. The author of over 20 scientific papers and book chapters, Dr. Mazzo is responsible for all pharmaceutical development activities (Analytics, Pharmaceutics, and Biodynamics) at HMR sites in England, France, Germany, Japan, and the United States. He has held managerial and directorship Positions at Merck, Sharp and Dohme, Baxter Healthcare. and Rhone-Poulenc Rorer. Dr. Mazzo is a frequent speaker at international technical meetings and is a member of the ICH working group for stability for the EFPIA.
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