Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence [BE/BA News]

posted by Achievwin – US, 2023-02-07 08:13 (52 d 21:37 ago) – Posting: # 23441
Views: 990

Wishful thinking: I hope they give clear direction (kill once for all) - the annoying center/group effect portion for BE studies conducted in one country and in homogenous population.

As many times and on many platforms they mentioned it is irrelevant in BE/ANDA contecxt some academic curiosity folks keep brining this topic and keep the topic alive.

❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence


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