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Abstract Details
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Activity Number:
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13
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304028 |
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Title:
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Utilizing Modeling and Simulation to Optimize Phase 2 for Decisionmaking
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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 Ctr, Indianapolis, IN, 46285-0001, United States
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Keywords:
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Design ;
Phase 2 ;
Simulation ;
Modeling
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Abstract:
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The size of a phase 2 clinical trial is often constrained by an average budget set by stage of development. Within this constraint, modeling and simulation can be used to design a trial and decision criteria that will increase the likelihood of making good development decisions. The trial design and decision criteria need to be jointly developed. However, in order to optimize phase 2 with the end in mind, the impact on phase 3 needs to be assessed. In this presentation, using modeling a simulation to design a trial and development decision rules jointly will be illustrated. The extension to simulating phase 2 and 3 to optimize phase 2 will also be illustrated.
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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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