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 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