A first look [BE/BA News]

posted by BRB  – Canada, 2022-12-02 19:20 (535 d 15:18 ago) – Posting: # 23379
Views: 6,111

Hi J,
No, it's still there. See lines 260-261:

The number of evaluable subjects in a PK BE study should not be less than 12. For highly variable drug products, a minimum of 24 subjects are recommended for BE assessment.

❝ Almost a complete overhaul. Very detailed. I notice something, they removed the min sample size requirement of n=12 (Unless it's written in later part of the doc)


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