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Abstract Details
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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 - #302808 |
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Title:
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Adaptive Design for Bioequivalence Clinical Trials
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Author(s):
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Fengjuan Xuan*+ and Ferdous Gheyas
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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2015 Galloping Hill Road, Kenilworth, NJ, 07033, USA
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Keywords:
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Adaptive design ;
bioequivalence ;
conditional power ;
futility assessment ;
clinical trial
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Abstract:
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Adaptive design have been applied to superiority clinical studies to reduce drug development cost, while the application in bioequivalence studies is much less researched. Traditionally, a pilot study with a small sample size is conducted before a pivotal bioequivalence study to collect information such as variability and the GMR (geometric mean ratio) for comparing the experimental formulation with the reference formulation. This traditional drug development process is very time-consuming and costly. Therefore, adaptive bioequivalence study with two stages can significantly reduce the drug development cycle, and the cost of new drug. This presentation will discuss the design of a pivotal bioequivalence study where a futility assessment is performed at the interim analysis by an independent statistician . A closed-formula were derived to calculate the conditional power for repeated crossover design as well as other complex 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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