Bioequivalence and Bioavailability Forum

Hello Everyone,

Hope all good !!!

This is regarding one BE study on Clarithromycin Extended-Release Tablets, USP 500 mg conducted on healthy male subjects for USFDA regulatory.
Received query regarding explanation/scientific justification to support that the BE results from the male-only study can be extrapolated to the entire population consisting of both sexes and that the difference in study population will not affect the BE conclusion.

Searched literatures, but could not get any relevant data to conclude on above query. Your expert opinion is needed. How to handle this query?.

thanks to all.

Have a great day ahead.