International Stability Testing (Hardcover)

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.

General

Imprint:	Crc Press
Country of origin:	United States
Release date:	August 1998
First published:	1998
Editors:	David J. Mazzo
Dimensions:	254 x 178 x 26mm (L x W x T)
Format:	Hardcover
Pages:	352
ISBN-13:	978-1-57491-078-0
Categories:	Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing Books > Medicine > General issues > Medical equipment & techniques > Medical research Books > Medicine > Other branches of medicine > Pharmacology > General
LSN:	1-57491-078-7
Barcode:	9781574910780

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