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

posted by dshah  – India/United Kingdom, 2022-09-20 18:02 (525 d 11:33 ago) – Posting: # 23309
Views: 2,218

Dear Rayhope:
The decision tree is from article: In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report.
Regards,
Divyen

Complete thread:

UA Flag
Activity
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
26 visitors (0 registered, 26 guests [including 4 identified bots]).
Forum time: 04:36 CET (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

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