Use data of all dosed subjects [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2019-09-19 15:16 (397 d 15:05 ago) – Posting: # 20617
Views: 4,076

Hi Elena,

» […] What combined data should be evaluated after stage 2 completion: ONLY for Cmax or for Cmax and AUCt?

Whatever drives the second stage, you have to use all data (Cmax and AUC). Whilst from a statistical perspective there would be no need to assess AUC (already BE in the first stage) no regulator would accept that. Once you dosed subjects, you have to use the data. No way out.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,170 posts in 4,411 threads, 1,474 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Wednesday 06:22 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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