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

posted by wienui  – Germany/Oman, 2022-09-06 01:29 (154 d 21:45 ago) – Posting: # 23270
Views: 1,619

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

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