International Stability Testing: 1st Edition (Hardback) book cover

International Stability Testing

1st Edition

Edited by David J. Mazzo

CRC Press

352 pages

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Hardback: 9781574910780
pub: 1998-08-31

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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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology