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Abstract Details
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Activity Number:
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228
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Bayesian Statistical Science
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| Abstract - #305262 |
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Title:
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Implementing Bayesian Methods in Biological Product Development: Regulatory Perspective and Experience
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Author(s):
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Boguang Zhen*+
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Companies:
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FDA/CBER
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Address:
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1401 Rockville Pike, Rockville, MD, , United States
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Keywords:
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Bayesian ;
therapeutic product ;
Regulatory perspective
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Abstract:
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Recently, there are an increasing number of protocols with Bayesian methodology in therapeutic biological product development submitted to CBER/FDA for review. Some of these studies are designed for supporting licensing application and many are at the stage of early phase clinical trial development. The presenter will first summarize the types of Bayesian approaches commonly seen in the submissions, and then share the review experience for such submissions. Issues and challenges in reviewing protocols with Bayesian methodology will be presented and discussed with some hypothetical examples. The talk will also focus on the use of Bayesian approach in confirmatory trials.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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