Bioequivalence and Bioavailability Forum

Hi all,

Being a long time reader but this is my first post. So Helmut, just to let you know I did read Forum Policy first and did a search before posting.

So here it goes. There's this chemical, reference product (X) is modified release formulation (pellets in capsule) with 2 strength, say, A1 and A2. We did 2 BE studies with the higher strength and everything's OK and we should be able to obtain MA for generic of this reference.

The trick is that this chemical also has another brand name (Y, from same innovator) with different indication and different strength, say B1 and B2. also modified release pellets in capsule.

Now the question is that if we can market our generic product for reference Y without doing additional BE study. The idea is to persent dossier with strength B1 and B2 requesting MA of generic for reference Y, but quoting the data from BE studies of strength A1 (the highest of the 4 strengths). PK is linear by the way.

My personal impression is that we might have to repeat 2 BE studies with Y as reference since the indication is changed but I'm not sure . My colleague from business dpt want no BE at all (understandably though).

Can anyone point some web/reference/guideline to me to look in detail? And any opinion/suggestion is welcome. Thanks.

Shuanghe