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

posted by wienui  – Germany/Oman, 2022-09-06 01:29 (89 d 11:40 ago) – Posting: # 23270
Views: 1,168

Hi Divyen,

❝ You guess it right John.

❝ Kindly refer below PSG for example.


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

and here

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"


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