Parallel Group Adaptive Designs [Two-Stage / GS Designs]

posted by Achievwin – US, 2024-01-05 12:53 (196 d 09:31 ago) – Posting: # 23819
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I am thinking of using two stage approach for a parallel BE study (in patients) is there an accepted procedure for sample size calculations? at stage 1 and stage 2?

Any instances where FDA accepted a two stage design methodology for calculating samples size for stage 2 after reviewing stage 1 results?

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