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International Stability Testing

Name: International Stability Testing
Brand: CRC Press
SKU: 39855645
Price: 251.1 EUR
Availability: InStock
Author: David J. Mazzo
ISBN: 9781000161663

David J. Mazzo

Língua

Inglês

E-book Adobe ePub DRM

Código Libristo: 39855645

Editoras CRC Press, agosto 2020

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

Código Libristo: 39855645

608 b

251.10 €

Em stock Imediatamente descarregável

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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.