Multi-group studies ad nauseam [BE/BA News]

posted by Achievwin – US, 2023-02-25 17:18 (513 d 10:24 ago) – Posting: # 23475
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The FDA? Where?

Outlined in FDAs Statistical approaches for BE studies guidance in lines 516-544 clearly stats do your analysis on complete population (not to split hair on groups :-D ). My experience group effect is critical when heterogenous ethnic population across multiple continents are recruited and contributing to disproportional variability and results skewing the final outcome.

Hope it churns more academic discussion and we MAY have some clarity before I retire.....:-D:-D:-D

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