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Abstract Details

Activity Number: 343
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305900
Title: Optimizing Bioequivalence Trial Sample Size
Author(s): Bret Musser*+ and Junghoon Lee and Larson Patrick
Companies: Merck and Merck and Merck
Address: 126 E. Lincoln Avenue, Rahway, NJ, 07065, United States
Keywords: clinical trial ; bioequivalence ; sample size ; simulation ; modeling ; pilot study

Bioequivalence is the assessment that two formulations of a drug are the same. The strategy for establishing bioequivalence typically involves conducting two clinical studies: a probe (pilot) study which, if successful, may be followed by a definitive bioequivalence study. Of key interest are the design of the pilot study and the rules used to decide whether or not to conduct the definitive study. We have built a simulation model of the bioequivalence trial process, so that we can assess the effect of different design and decision-making strategies on the success and failure rates for achieving bioequivalence, as well as for estimating costs and timelines. Using the model, we have shown that small pilot studies are too imprecise to make accurate decisions, and subsequently increase the total cost of development of a new formulation. There is also a point beyond which increasing the size of the pilot study increases overall cost.

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