Dissolution and bracketing - EMA [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-20 11:38 (252 d 20:33 ago) – Posting: # 21290
Views: 1,784

Hi Susanh,

We do face difficulties with the BCS IV drugs with low solubility.

If the reference product doesn't behave as the test product in Disso profile, you need to reformulate. What are your F values? Do you have separate F values with different strengths? If yes, pl share.

IMO, even if you follow the bracketing approach, you will have to prove the disso data for each strength you plan to register.

Could BE-studies been done on the highest and lowest strength and not on middle strengths in this case?

Yes, In Vivo BE studies can be done on the highest and lowest strengths.

Cheers, SKM

Complete thread:

Activity
 Admin contact
21,215 posts in 4,427 threads, 1,482 registered users;
online 26 (0 registered, 26 guests [including 11 identified bots]).
Forum time: Saturday 08:12 CET (Europe/Vienna)

Science may be described as the art of systematic over-simplification –
the art of discerning what we may with advantage omit.    Karl R. Popper

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5