discriminatory methods? [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2014-04-04 12:43 (3763 d 04:44 ago) – Posting: # 12766
Views: 9,940

Dear mahonny
Keeping in mind that both drugs are good soluble the results you present look rather strange and I would not draw any conclusion from these data. I suggest to evaluate if your method is discriminatory. In case of BCS class I and III substances you would expect dissolution profiles which show a rapid onset with more than 85% dissolution after 15 min. or at least after 30 min. and about 100% at the end for each pH level. If you show this for the reference product you can evaluate if your products is suitable.
I hope this helps
Dr_Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,119 posts in 4,859 threads, 1,647 registered users;
38 visitors (1 registered, 37 guests [including 6 identified bots]).
Forum time: 17:27 CEST (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

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