Shein-Chung Chow

Statistical Design and Analysis of Stability Studies (eBook, ePUB)

• Format: ePub

Produktbeschreibung

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Erscheinungstermin: 30. Mai 2007
• Englisch
• ISBN-13: 9781040160374
• Artikelnr.: 73302712

Autorenporträt

Shein-Chung Chow

Inhaltsangabe

Introduction. Accelerated Testing. Expiration Dating Period. Stability
Designs. Stability Analysis with Fixed Batches. Stability Analysis with
Random Batches. Stability Analysis with a Mixed Effects Model. Stability
Analysis with Discrete Responses. Stability Analysis with Multiple
Components. Stability Analysis with Frozen Drug Products. Stability Testing
for Dissolution. Current Issues and Recent Developments. Appendices.
References. Index.