Bioequivalence and Bioavailability Forum • US (or EU) ANDA: Fail f2 but pass BE?

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

posted by jag009 – NJ, 2022-09-05 01:13 (1392 d 04:26 ago) – Posting: # 23267
Views: 8,376

HI Divyen,

❝ I think the talk is about BE strength only, but what about other strength waiver?

You meant if f2 fails between strengths for a strength waiver?

John

Complete thread:

US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-01 22:16
- US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-01 23:22
  - US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-02 00:29
    - US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-02 11:37
      - US (or EU) ANDA: Fail f2 but pass BE?jag009 2022-09-04 23:13
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-05 11:16
        
        US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-05 23:29
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-06 00:49
        
        US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-08 19:32
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-09 17:56
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-15 11:09
        
        US (or EU) ANDA: Fail f2 but pass BE? Rayhope 2022-09-15 15:13
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-20 16:02

Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
382 visitors (0 registered, 382 guests [including 24 identified bots]).
Forum time: 05:39 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks. Jimmy Wales

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz