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Abstract Details
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Activity Number:
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9
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Type:
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Invited
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300369 |
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Title:
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The Use of Drug Disease Models and Biomarkers in Trial Design
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Author(s):
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Brenda Gaydos*+
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Companies:
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Eli Lilly and Company
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Address:
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Lilly Corporate Center, Indianapolis, IN, 46285 ,
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Keywords:
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modeling ;
biomarkers ;
simulation ;
design ;
adaptive
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Abstract:
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Drug disease models can be leveraged to improve trial design. For example, virtual patient responses can be simulated from drug disease models and used to assess a design's performance. If a trial performs poorly under this scenario of truth, the design needs to be modified. Knowledge of drug disease models can also be leveraged in the selection of final data analysis models and the definition of prior distributions if a Bayesian analysis is employed. Adaptive designs require simulation to understand the operating characteristics of the design, and the use of both drug disease models and biomarkers can improve performance. In this presentation, several examples (fixed designs and adaptive designs) will be presented where drug disease models and biomarkers have been used to optimize design.
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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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