Bioequivalence and Bioavailability Forum

❝ What if we want to perform clinical trials to satisfy requirements of 'add-on' indications? Should we still reformulate our product to have bioequivalence for both Cmax and AUCt vs. individual components? We think that Cmax is not relevant for the clinical effect, as medications are taken continiously for a very long time periods.

Hello

In my opinion Cmax is important BE studies if the RMP is administraded by specific route, (like subcutaneous) or has an clinical impact in this case mayors guideline like EMA and FDA demands it as a coprimary endpoints (toguether with AUC)

the regulatory authorithies demands a mean value for both product or demonstrade one primary endpoint is enough for bioequivalence (like intravenous infusion when F=100%)

I hope this explanation help you a little

best regards