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

posted by dshah  – India/United Kingdom, 2022-09-05 13:16 (90 d 00:53 ago) – Posting: # 23269
Views: 1,221

Hi John!
You guess it right John.
Kindly refer below PSG for example.
So, if only BE strength is in the focus, there is no need to worry.

Complete thread:

UA Flag
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
12 visitors (0 registered, 12 guests [including 6 identified bots]).
Forum time: 13:09 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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