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

posted by Helmut Homepage – Vienna, Austria, 2022-01-28 22:06 (759 d 16:52 ago) – Posting: # 22758
Views: 1,385

Hi Sereng,

❝ […] The PSG also asks us to use the RSABE approach for properly adjusting the BE acceptance criteria based on "reference variability…

So far so good.

❝ … and comparing test and referenced product within-subject variability".

That’s rather unusual. Can you post a link to the guidance?

❝ 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?

No, that’s wrong. See there.

❝ […] would there be any additional sample size efficiency arising from the use of the RSABE?

The idea behind RSABE is to maintain power independent from the CV.

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