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, 2022-09-08 21:32 (592 d 15:50 ago) – Posting: # 23280
Views: 2,832

Hi,

❝ You guess it right John.

If you fail f2 comparison between highest and lowest (or other) strengths then they wont grant you the waiver unless you run bio, even if you claim formulations are proportional.

John

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