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Life Cycle Management of the Stability of Pharmaceuticals and Medical Devices

Life Cycle Management of the Stability of Pharmaceuticals and Medical Devices

Q. Chan Li, Terrence P. Tougas, Reginaldo A. Saraceno

ISBN: 978-1-119-07665-0

May 2017

528 pages

Select type: Hardcover

$195.00

Product not available for purchase

Description

This book provides practical information on the fundamentals, strategies, and regulations for testing the stability of drugs and medical devices. A key aspect of the book is its review of global regulatory requirements and expectations from around the world, including unique information on stability in context of quality by design (QbD). Other sections deal with packaging development strategies, analytical methods and techniques, best practices for drugs, and an assessment of future trends like the impact of new manufacturing technologies. Reliant on a heavy use of case studies, the book offers a valuable insight into the experiences and practices from leading contributors on the frontlines of the pharmaceutical and medical device industries.