Bioequivalence and Bioavailability Forum • Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design

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

posted by Helmut – Vienna, Austria, 2022-01-28 21:06 (151 d 20:51 ago) – Posting: # 22758
Views: 594

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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Complete thread:

Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 19:37 [RSABE / ABEL]
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation DesignHelmut 2022-01-28 21:06
  - Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 21:40
    - NTIDs Helmut 2022-01-29 12:19