Dissolution and bracketing - EMA [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-20 11:38 (341 d 09:12 ago) – Posting: # 21290
Views: 1,937

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
21,355 posts in 4,458 threads, 1,493 registered users;
online 11 (0 registered, 11 guests [including 2 identified bots]).
Forum time: Wednesday 20:51 CET (Europe/Vienna)

It is better to be wrong than to be vague.
In trial and error, the error is the true essential.    Freeman Dyson

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