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Pharmaceutical Stability Testing to Support Global Markets

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ISBN-10: 1441908889

ISBN-13: 9781441908889

Edition: 2010

Authors: Kim Huynh-Ba

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This book is a proceedings of the AAPS Stability Workshop. This workshop provide an understanding of the regulatory perspective of Stability Testing and position the stability program for 21st century globally by: Learning regulatory initiatives on global stability submissionStability testing in challenging storage environment such as ASEAN or Caribbean region.Exploring concept of Quality by Design as it applies to stability testingUnderstanding stability challenges of biologics, generics, nutraceutical, and other new product technologySetting specifications for Drug Substances as well as various type of drug productsExploring concerns on changes of stability profiles such as repackaged…    
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Book details

Copyright year: 2010
Publisher: Springer New York
Publication date: 12/17/2009
Binding: Hardcover
Pages: 266
Size: 7.01" wide x 10.00" long x 0.25" tall
Weight: 1.782
Language: English