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 safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.
After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.
To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.
Table of Contents
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.
"…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