Two-stage design and 'forced bioequivalence' [Two-Stage / GS Designs]

posted by Mikalai  – Belarus, 2018-06-06 08:28 (959 d 00:55 ago) – Posting: # 18854
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(edited by Mikalai on 2018-06-06 08:44)

Dear all,
We plan to conduct a sequential (two stage) BE study, and I am concerned with "forced bioequivalence". Specifically, if we obtain non-equivalent results in the first stage with very low power and should recruit more volunteers, how can we protect ourselves from getting into "forced bioequivalence"? In other words, how can we differentiate between underpowered trials and non-equivalent results in the sequential BE? And how can we put this (protection against "forced bioequivalence") in the protocol not to raise many questions from regulators?
Any suggestions and advice will be appreciated.
Sincerely,
Mikalai

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