Bioequivalence and Bioavailability Forum

Sorry for this question but I am totally new to the field of bioequivalence and I have the following case:

A single dose, two sequence and two period- crossover bioequivalence study with 32 subjects fails to show bioequivalence because the criteria for AUC 0-t were not met (76.62-102.75%) but Cmax is clearly within the limits (81.71-109.23%). T/R of Cmax was 94.47% and T/R of AUC 0-t was 88.73%. CV% was 42.89% for Cmax and 46.99% for AUC 0-t of the test product.

The dissolution profiles have already revealed a tendency of slower dissolution rates of the test formulation although statistically from the f2 values similarity was concluded.

Since the test product fails to meet only the lower end of the criteria for AUC 0-t it is not truely bioinequivalent. Could it be possible that bioinequivalence was demonstrated accidentally although the two products are actually bioequivalent? How could this be proven?

In the study protocol I have read: “A formal statistical calculation of the study’s power was not carried out (given the scarce literature on intraindividual variability and confidence intervals for ivermectin).” Is it therefore really only possible to guess the sample size?

Would it be advisable to perform another bioequivalence study with the same design?

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Edit: Category changed. [Helmut]