Bioequivalence and Bioavailability Forum

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

posted by dshah  – India, 2022-09-15 13:09 (725 d 08:10 ago) – Posting: # 23296
Views: 3,430

Hi John!
Below decision tree might help you.

Regards,
Divyen

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