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

posted by Yura – Belarus, 2018-06-07 10:24  – Posting: # 18859
Views: 2,293

Hi Mikalai,
'forced bioequivalence' - it's not from "that opera".
If you took for 2х2х2 n = 120 for CL AUCt (90-111.11 - with narrow therapeutic index), CV = 16.5% and recommended GMR = 97.5%, while in calculation (in R) for 2х2х4 you get n = 30.
The sample size is twice as high as possible, which is not ethical - to expose an unknown effect of the test drug to more people than necessary.
If I understand correctly, that's it 'forced bioequivalence'
regards

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