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Wednesday, September 25
Wed, Sep 25, 9:45 AM - 10:30 AM
Marriott Foyer
Poster Session

Improved Tests for Bioequivalence Using Bootstrap Calibration (300928)

*Rabab Elnaiem, University of Maryland Baltimore County 
Thomas Mathew , University of Maryland Baltimore County 

Keywords: Bioequivalence, similarity, bootstrap calibration, overlap coefficient, fiducial.

A common bioequivalence criterion is the average bioequivalence (ABE), testing if the difference of appropriate mean responses is within a predefined limit. A popular test for ABE is the two one-sided t-test (TOST). The TOST is conservative as the variability increases. While this may not always be a practical concern, we noticed that this conservatism can be fixed by applying a bootstrap calibration, making the type I error closer to the nominal level and significant gain in power.

For assessing equivalence, an evaluation of the similarity between the distributions of the responses can be used as an alternative criterion. We propose the use of the overlap coefficient (OVL), which is the area of overlap between two probability distributions, as a measure of similarity between distributions. Using a fiducial approach, we have explored the computation of confidence limits for the OVL value.