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Activity Number: 591
Type: Topic Contributed
Date/Time: Thursday, August 6, 2009 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #303978
Title: Bayesian Analyses of Binary Outcomes
Author(s): Chunrong Cheng*+ and Tie-Hua Ng
Companies: FDA and FDA
Address: , , 20852,
Keywords: Bayesian ; Binary
Abstract:

The safety parameter in the evaluation of a factor VIII product is the inhibitor rate denoted by ?, that is, the proportion of subjects who develop inhibitors. Assuming ? follows a beta distribution, various Bayesian models/approaches using a real example will be presented. The advantages/disadvantages and the assumptions of these approaches will be discussed. Sample size calculation will be presented.

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