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 (1033 d 09:09 ago) – Posting: # 23267
Views: 5,435

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
23,427 posts in 4,929 threads, 1,679 registered users;
81 visitors (0 registered, 81 guests [including 51 identified bots]).
Forum time: 10:23 CEST (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important. T. S. Eliot

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz