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International Stability Testing

Name: International Stability Testing
Brand: CRC Press
SKU: 39855645
Price: 263.5 EUR
Availability: InStock
Author: David J. Mazzo
ISBN: 9781000161663

David J. Mazzo

Language

English

E-book Adobe ePub DRM

Libristo code: 39855645

Publishers CRC Press, August 2020

In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical... Full description

Libristo code: 39855645

638 b

263.50 €

In stock Immediate digital delivery

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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.