291 – Methods of Reliability and Life Testing
Rejecting Poolability in Simple Drug Stability Studies
Sponsor: Quality and Productivity Section
Keywords: Stability Analysis, Hypothesis Testing, Sequential Testing, Simultaneous Testing, Model Selection, Federal Guidelines
Michael T. Crotty
SAS Institute
Peng Liu
SAS Institute
Liansheng Zhu
Novartis
While working on implementing a procedure to help practitioners determine the shelf life of a drug, we made some interesting ndings. There are di erent interpretations about which approach to follow. We are aware of three approaches, which we compare using a simulation study. We will present the background of the study, descriptions of the three approaches, and comparisons among those approaches.
