TSD: BE in stage 1 [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2018-01-19 13:21 (1894 d 18:01 ago) – Posting: # 18224
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Hi Yura,

❝ If in carrying out a two-stage design in the first stage with N = 20 subjects bioequivalence is shown, what should be done with the second stage?

Open a bottle of champagne, since there is no need for a second stage (see the left branches of the flowcharts in this post). BTW, all of my TSDs passed in the 1st:-D
AFAIK, only the Indonesian agency requires a “second stage” in such a case for reasons I fail to comprehend. Think about a fixed-sample study which passed BE: would anybody ask for another one? IIRC, ElMaestro wrote a paper* about it (I’m traveling and can’t check).


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