Bioequivalence and Bioavailability Forum

Dear colleagues,

We have conducted an in-vitro permeation pilot study for confirming the suitability of our design in terms of time points, duration and for estimating the sample size for the pivotal study based on the within-reference %CV and the GMR calculated. The GMR was approximately 1.19 and the %CV around 25%. As it can easily be inferred the 90% C.I did not fall within the 0.80-1.25 interval. I realize that no safe conclusions can be drawn from a very small sample size regarding the equivalence of the products but i wonder if there is an established methodology for assessing if there is any point in proceeding with the pivotal study.

Thank you,

Best regards,

Constantinos

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Edit: Category changed; see also this post #1. [Helmut]