Bioequivalence and Bioavailability Forum

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

posted by dshah  – India/United Kingdom, 2022-09-05 13:16 (597 d 04:54 ago) – Posting: # 23269
Views: 2,979

Hi John!
You guess it right John.
Kindly refer below PSG for example.

So, if only BE strength is in the focus, there is no need to worry.
Regards,
Divyen

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