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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, August 1, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301799 |
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Title:
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Examples of Safety and Efficacy Analyses in Early Clinical Development Incorporating Historical Data
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Author(s):
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Neal Thomas*+
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Companies:
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Pfizer Inc.
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Address:
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61 Dreamlake Drive, Madison, CT, 06443, USA
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Keywords:
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Bayes ;
historical data ;
safety assessment ;
dose response
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Abstract:
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Several examples will be presented which used historical data to create Bayesian prior distributions. The examples include settings in which internal patient level data are available, and settings in which only published historical summaries are available. Some of the prior information is compound-specific, and some of it is based on broader experience with drug development. Applications include safety and efficacy assessments.
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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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