International Stability Testing

ISBN-13: 9781574910780 / Angielski / Twarda / 1998 / 352 str.

Mazzo J. Mazzo; David J. Mazzo

Opis

Provides the only single-volume reference for stability requirement in all major markets Discusses all aspects of stability testing, including ICH stability guidelines Supports the text with real-world examples 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.

Spis treści

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. HelboePreservative Activity During Studies, N. Hodges Substances Solid-State Characterization & Stability, I. Santos Europe: Requirements, A. CartwrightPostapproval FDA Requirements, D. Shah Japan, S. Yoshioka Australia, S. Walters WHO, S. Kopp-Kubel & M. Zahn Non-ICH Areas, T. Beaumont

O autorze

David J. Mazzo