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

posted by Helmut Homepage – Vienna, Austria, 2019-09-19 15:16  – Posting: # 20617
Views: 801

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.

Cheers,
Helmut Schütz
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