Sample Size Effi­ci­ency of 4-Period, 2-Seq, 2-Formu­la­tion Design [RSABE / ABEL]

posted by Sereng  – USA, 2022-01-28 20:37 (309 d 08:47 ago) – Posting: # 22757
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Folks, I really appreciate the guidance from this Forum. We need to conduct a 4-Period, 2-Sequence, 2-Formulation BE study per FDA "product specific guidance" (PSG). The PSG also asks us to use the RSABE approach for properly adjusting the BE acceptance criteria based on "reference variability and comparing test and referenced product within-subject variability". Can we safely assume that conducting such a replicate study would (at least) reduce our sample size by 50% over a 2-Period, 2-Sequence, 2-Formulation BE study? If correct, and assuming no more dropouts (from the longer study), would there be any additional sample size efficiency arising from the use of the RSABE? Any help would be much appreciated! Many thanks!

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