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

Contents

About the Author