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

posted by dshah – India, 2021-07-17 11:44 (12 d 15:15 ago) – Posting: # 22474
Views: 103

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.

Complete thread:

 Admin contact
21,592 posts in 4,514 threads, 1,532 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Friday 03:00 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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