Bioequivalence and Bioavailability Forum

Dear Govardhan!

First have a look at Ace’s reply. It looks the the US and the EU product differ in the first 15 minutes…

❝ […] we have done the comparative dissolution studies for both RLD (US and EU).

There’s no “EU RLD”! For a European submission for marketing authorisation an innovator’s product from any European member state may be used as a reference. It is well known that innovator's products may differ from country to country… So maybe you just picked a ‘bad’ one…
CROs make their (good?) living from in vivo studies; you can place a bet that all sponsors have done a lot to match the reference’s in vitro profile. If the dissolution is not triggered by the formulation (i.e., MR), trying to match the reference is nice – but you will have to perform a biostudy anyway. Maybe if criteria are fulfilled (ƒ₂, ), studies for different strengths will be waived.