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

posted by Yura – Belarus, 2018-06-07 10:24 (793 d 17:34 ago) – Posting: # 18859
Views: 2,972

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

Complete thread:

Activity
 Admin contact
20,984 posts in 4,374 threads, 1,460 registered users;
online 13 (0 registered, 13 guests [including 8 identified bots]).
Forum time: Sunday 03:59 CEST (Europe/Vienna)

The interpretation of facts in a certain way
stimulates other scientists’ thoughts.    Róbert Bárány

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5