Bioequivalence and Bioavailability Forum

Dear Jayesh
How do you know that the US reference product has the same formulation as the European reference product? You will never know! I also tried once but the agencies did not accept the argument US RLD = EU RLD although there was worlwide only one production site and the qualitative composition was the same. A single 3WC study using RLD from USA and EU bears the risk that one comparison fails. The consequence would be that you present unfavourable data to the agency. In case when everything is fine nobody would ask, in case of failure you have to find strong arguments how you selected your reference batches. This might lead to endless discussions. I strongly recommend to perform two studies, one for the US market and one for Europe.
O.K. I agree that it is more expensive but you are on the safe side.
Kind regards
Dan