Latest version of ASEAN BABE GL [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-05-19 21:11 (4790 d 05:32 ago) – Posting: # 10602
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Dear all,

does anybody know where I can find the latest release? Version 5 (July 2012) of the Q&A contains this goodie:

Q2: In case of 2 stage design study, how many subjects are recommended to start with in the first stage? If the first stage can reach BE, but the intra subject CV is high and the number of subjects is not enough to obtain the required statistical power, are additional subjects still needed?

A2: Since this situation has been addressed in the new ASEAN Guidelines on BABE, kindly refer to paragraph 3.1.3 (Number of Subjects) and 3.1.8 (Evaluation, Two-Stage Design).


Given this thread I’m really curious what Section 3.1.8 might tell.

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