Bracketing approach for multiple strenght product EMA [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2021-07-17 13:44 (984 d 21:28 ago) – Posting: # 22474
Views: 957

Dear J!
If the dissolution is more than 85% in 15 min, then F2 would not be applicable. However, for multimedia dissolution for a BCS class II drug, there is a high possibility that in at least one media, the dissolution would be slower and thus F2 can be applied.
Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,640 registered users;
81 visitors (0 registered, 81 guests [including 5 identified bots]).
Forum time: 10:13 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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