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 Rayhope – India, 2022-09-15 17:13 (919 d 06:26 ago) – Posting: # 23298
Views: 4,385

❝ Below decision tree might help you.

❝ [image]

HI Divyen ,
Please let me know from where u got this flow chart. Please name the guidance will be helpfull.

Complete thread:

US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-01 22:16 [Regulatives / Guidelines]
- 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
23,409 posts in 4,921 threads, 1,670 registered users;
14 visitors (0 registered, 14 guests [including 8 identified bots]).
Forum time: 22:39 CET (Europe/Vienna)

Facts are meaningless. You could use facts to prove
anything that’s even remotely true! Homer Simpson

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz