350 Pages
by
CRC Press
352 Pages
by
CRC Press
Also available as eBook on:
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,... Read more
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
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
Biography
David J. Mazzo
