US (or EU) ANDA: Fail f2 but pass BE? [Regulatives / Guidelines]

posted by dshah  – India, 2022-09-09 19:56 (1016 d 00:08 ago) – Posting: # 23290
Views: 5,165

Hi John!

❝ If you fail f2 comparison between highest and lowest (or other) strengths then they wont grant you the waiver unless you run bio, even if you claim formulations are proportional.


You can try multi tablet for dissolution, or perform bootstrap for f2, try model dependent and independent approaches to prove similarity in dissolution.

Regards,
Divyen

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
52 visitors (0 registered, 52 guests [including 11 identified bots]).
Forum time: 20:04 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling.    Stephen Senn

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