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 (1015 d 23:26 ago) – Posting: # 23267
Views: 5,326

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 [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

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