This monkey business [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2013-06-13 23:33 (4754 d 19:29 ago) – Posting: # 10783
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Hi John!

❝ […] Okay, it's from the 2001 guidance and RSABE was introduced much later...


I think that’s the crucial point. At a Pharmaceutical Science Advisory Committee Meeting FDA suggested a minimum of 36 subjects and was voted down (have to dig out the reference). From what I’ve heard at conferences they want 24 – but I was never able to find a reference.

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