Bioequivalence and Bioavailability Forum • same drug substance, 2 brands with different strengths

wanabby
☆

2012-03-08 05:52
(5226 d 12:15 ago)

Posting: # 8231
Views: 1,545

same drug substance, 2 brands with different strengths [Regulatives / Guidelines]

Dear all,

This is my first post and I did a search before posting. the similar topic with my question is (http://forum.bebac.at/mix_entry.php?id=6772#p6772),but mine is absolutely not the same.

Get down to the business,I have a problem, we would like to submit a ANDA in Germany, but the RLD (R) has 4 strengths, and the lowest stength(R1) has a different brand name(AOO) with the other 3 Strengths (AOB). If the dissolution of AOO is different with AOB.

Whether we should conduct 2 BE studies with the lowest strength and the highest strength?
and if we can make our the dissolution of our 4 preparations the same, can we only conduct one BE Study with the highest strength?

Can anyone give some reference/guideline to me in detail? Thanks a million.

Abby