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To explore the comparative performance of the recently proposed bioequivalence (BE) approaches, FDA_s and EMA_s, by the FDA working group on highly variable drugs and the EMA, respectively; to compare the impact of the GMR-constraint on the two approaches; and to provide representative plots of % BE acceptance as a function of geometric mean ratio, sample size and variability.

Simulated BE studies and extreme GMR versus CV plots were used. Three sequence, three period crossover studies with two treatments were simulated using four levels of within-subject variability.

The FDA_s and EMA_s approaches were identical when variability was <30%. In all other cases, the FDA_s method was more permissive than EMA_s. The major discrepancy was observed for variability values >50 …