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Abstract Details
Activity Number:
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516
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #302445 |
Title:
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A Three-Part Adaptive Design with POC and Dose-Finding for Induction Regimen and Dose-Finding for Maintenance Regimen for an Immunology Trial
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Author(s):
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Usha Barai*+
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Companies:
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Merck Research Laboratories
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Address:
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2015 Galloping Hill Road, Kenilworth, NJ, 07033-1300,
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Keywords:
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Adaptive ;
POC ;
Induction Dose Finding ;
Maintenance Dose Finding ;
Futility ;
Dropping/Adding Doses
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Abstract:
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In certain disease area like Crohn's disease (CD), it is important to establish optimal induction as well as maintenance dose regimen. This three Part trial incorporates Proof of Concept (POC), Induction Dose Finding and Maintenance Dose Finding using adaptive features like futility, dropping/adding induction doses and optimizing maintenance doses based on modeling. We will discuss important features of the trial design including interim analyses with quantitative decision criteria based on the results of the simulation studies and practical issues in adaptive designs.
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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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