1st Edition

International Stability Testing

Edited By

David J. Mazzo




ISBN 9781574910780
Published August 31, 1998 by CRC Press
352 Pages

USD $190.00

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Book Description

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

ICH Stability Guidelines, D. Mazzo
Photostability Testing, T. Beaumont
ICH Guidelines for Biological & Biotechnological Products, M. Haase
Stress Testing: Drug Substance Characterization, E. Pacaud
Statistical & Regulatory Aspects: FDA Perspective, W. Fairweather & T. Lin
Matrixing & Bracketing Designs: European Perspective, P. Helboe
Preservative Activity During Studies, N. Hodges
Substances Solid-State Characterization & Stability, I. Santos
Europe: Requirements, A. Cartwright
Postapproval FDA Requirements, D. Shah
Japan, S. Yoshioka
Australia, S. Walters
WHO, S. Kopp-Kubel & M. Zahn
Non-ICH Areas, T. Beaumont

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