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Statistical Design and Analysis of Stability Studies book cover

1st Edition

Statistical Design and Analysis of Stability Studies

By Shein-Chung Chow Copyright 2007
348 Pages
by Chapman & Hall

349 Pages 11 B/W Illustrations
by Chapman & Hall

349 Pages
by Chapman & Hall
Also available as eBook on:
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 stability studies play an important role in drug... Read more
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.

Biography

Shein-Chung Chow

"…This book provides a comprehensive and unified presentation of the principles and methodologies of design and analysis of stability studies. The text is well-written and provides a well-balanced summary of current regulatory perspectives. The primary SAS programs (macros) —comprising STAB—for estimating the expiration dating period of a drug product based on linear regression analysis are listed in the Appendix B and these macros help to reinforce the theory presented in the text. …"
—International Statistical Review, 2008

". . . serves as a useful reference for those who are interested in the statistical design and analysis of stability studies in drug research and development. Its clear explanation, plentiful illustrations, moderate mathematical exposition, and inclusion of SAS programming codes make all the materials accessible to most of the applied statisticians working in the biopharmaceutical environment."

– Ying Qing Chen, Fred Hutchinson Cancer Research Center, in JASA, March 2009

 

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