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Abstract Details

Activity Number: 522
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306367
Title: Simulation Study on Bioequivalence Tests Under Several Variability Conditions
Author(s): Denka Markova*+ and Dean Young
Companies: Axio Research Inc. and Baylor University
Address: 5110 17th Avenue NW, Seattle, WA, 98107, United States
Keywords: bioequivalence ; within-subject variability ; between-subject variability ; generic drugs ; test and reference formulations ; mean ratio difference

We eliminate the effect of several parameters on a bioequivalence testing procedure that plays an important role in the development of generic drugs. The current FDA criteria are not flexible with respect to highly variable drugs, and this characteristic has caused many good drugs to be rejected. Most often in the literature, we find studies examining the sample size or the within-subject variability as the main factors affecting the outcome of a bioequivalence test. Frequently, pharmaceutical companies have tried to convince the FDA that their product would meet the bioequivalence criteria just by increasing the sample size. Here we examine the effect of the between-subject variability as well as the effect of the mean ratio difference between the test and reference formulations. We use a Monte Carlo simulation to draw conclusions based on the importance of these two sources of variability and to show that simply increasing the sample size is insufficient to meet the bioequivalence criteria.

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