Bioequivalence and Bioavailability Forum

Hey John

❝ Does anyone have experience running clinical endpts BABE studies?

Yes, have done 2 studies
a) One for topical ointment
b) One for drug for treatment of obesity (it was mostly a PD endpoint study)

❝ If so, can you give a brief overview of the stats involved to demonstrate BE. I know it's not gonna be brief

I will keep it brief.

a) For Topical Ointment: Before starting the study we have submitted the protocols (prepared on the information obtained from FOI data and other published articles) to FDA asking for their recommendation and review of the protocols. FDA accepted most of the suggestion we proposed and came up with the guidance a couple of months later. Based on the usual method used in OGD for binary outcomes, the 90% confidence interval for the difference in success proportions between test and reference treatment must be contained within [-0.20, +0.20] in order to establish equivalence.
You can find all the detais in the guideline.

b) For drug for treatment of obesity: It was a PD endpoint Multiple-dose, 3-way crossover study consisting of two doses of reference product and at least one dose of the test product. The product should be administered as per the reference product labelling.
Data from the in vivo PD BE study should be statistically analysed using the Dose-Scale Method incorporating the Emax model. The 90% confidence interval for the relative bioavailability, F, must fall within 80-125% in order to establish bioequivalence. Details are available over here.

Just one suggestion, if the recommendations are not available for the molecule of interest, submit your protocols to FDA and ask for their recommendation.

Regards