2-Stage design [Two-Stage / GS Designs]

posted by balakotu – India, 2012-06-21 10:28 (4749 d 09:48 ago) – Posting: # 8821
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Dear all,

Please clarify following Criteria,

We are going to conduct one "Two-Stage" bioequivalence study. In this study initially we had fixed the sample size as maximum of 80 subjects (Both stage1 and stage2).

In stage-1 we include 40 subjects and based on stage1 data we will precede with a maximum sample size of 40 subjects in stage-2 (sample size will be ≤ 40).

Is there any statistical method to decide sample size in stage2?

Regards
Kotu


Edit: Category and subject line changed. [Helmut]

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