International Stability Testing
1st Edition
Published on 26. August 2020
352 pages
978-1-000-12296-1 (ISBN)
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.
More details
Edition
1. Auflage
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
Professional and scholarly
ISBN-13
978-1-000-12296-1 (9781000122961)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
David J. Mazzo
International Stability Testing
Book
08/1998
1st Edition
CRC Press
€252.20
Shipment within 3-4 weeks
Person
David J. Mazzo
Content
ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.
