GMR, theta 0 and that all [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2017-03-09 09:21  – Posting: # 17144
Views: 9,409

Dear Silva,

» What is the meaning of "True ratio of T/R for simulating" and what is the difference for GMR?

To obtain a value of the type 1 error or the power via simulations one has to create data for many studies, say 1 Mio, perform the TSD framework (using GMR=0.95 f.i., the A in Helmut's schemes above) on that data and count all studies in which BE was decided.

To create the study data you use the "True ratio of T/R" and the "True CV" and the statistical distributions relating these parameters to the observed outcomes of a study.

True ratio = 1.25 will create studies which are under the Null hypothesis "bioinequivalence" and counting studies which decide here nevertheless BE gives you the type I error "Null hypothesis true but decided as false".

Hope this was understandable.

Regards,

Detlew

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