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 wienui – Germany/Oman, 2022-09-06 01:29 (271 d 23:28 ago) – Posting: # 23270
Views: 1,965

Hi Divyen,

❝ You guess it right John.

❝ Kindly refer below PSG for example.

❝ [image]

I think you have asked this question several times and we have discussed it before, for example here:

https://forum.bebac.at/mix_entry.php?id=21680#p21742

and here
https://forum.bebac.at/mix_entry.php?id=22747#p22768

By the way, I will hold a presentation at The 4th MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis, and Dissolution about this topic on September 19th, 2022, in Amman, Jordan.

"Additional strength Biowaiver: Practical Regulatory Similarities & Differences Approaches"

http://rbbbd.com/IPRC_Program.aspx

—
Cheers,
Osama

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