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Abstract Details

Activity Number: 291
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Quality and Productivity Section
Abstract - #304996
Title: Rejecting Poolability in Simple Drug Stability Studies
Author(s): Peng Liu*+ and Michael T Crotty and Liansheng Zhu
Companies: SAS Institute and SAS Institute and Novartis
Address: 222 Rivanna Ct, Naperville, IL, 60565, United States
Keywords: Stability Analysis ; Hypothesis Testing ; Sequential Testing ; Simultaneous Testing ; Model Selection ; Federal Guidelines
Abstract:

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.


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