Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design [RSABE / ABEL]
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!
Complete thread:
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation DesignSereng 2022-01-28 19:37 [RSABE / ABEL]
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Helmut 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
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 21:40
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Helmut 2022-01-28 21:06