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Activity Number: 427 - Contributed Poster Presentations:Government Statistics Section
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 2:00 PM to 3:50 PM
Sponsor: Government Statistics Section
Abstract #329428
Title: New Proposal for Equivalence Criteria in Bioequivalence Study with Binary Clinical Endpoint
Author(s): Mengdie Yuan* and Jingyu Luan
Companies: Food and Drug Administration and Food and Drug Administration
Keywords: Equivalence; Binary endpoint; Rate difference; Relative risk

In comparative clinical endpoint studies with a binary outcome, a generic product (TEST) and the Reference Listed Drug (RLD) are considered to be equivalent if the 90% confidence interval for the difference in success or cure rates between the two products is within [-20%, 20%]. This method, however, is not equally sensitive for delimiting a difference between TEST and RLD across the response range. This is particularly problematic when the success rate for RLD is expected to be low. Therefore we propose a two-step method instead. Through simulation, we show that our proposed method can control the passing probability for products with relatively low success rate, and meanwhile maintain high power with reasonable sample size when Test and RLD are actually equivalent.

Authors who are presenting talks have a * after their name.

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