Statistical Design and Analysis of Stability Studies

"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 STABfor 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

Auteur

Shein-Chung Chow

Texte du rabat

Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing, focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods. The author compares some commonly employed study designs and discusses both

Contenu
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.