GMR, theta 0 and that all [Two-Stage / GS Designs]
Dear Silva,
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.
❝ 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
Regards,
Detlew
Complete thread:
- Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 06:40 [Two-Stage / GS Designs]
- Data for 2nd stage of Potvin’s designs ElMaestro 2017-02-18 10:20
- Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 13:29
- GMR = fixed! Helmut 2017-02-18 16:23
- Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 13:29
- “Type 1” slightly higher power than “Type 2” for the same adj. α Helmut 2017-02-18 11:51
- “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-18 13:31
- Terminology Helmut 2017-02-18 16:27
- Terminology Yura 2017-02-20 11:28
- Which GMR to plug in ElMaestro 2017-02-20 11:46
- Which GMR to plug in BE-proff 2017-02-21 11:35
- Which GMR to plug in ElMaestro 2017-02-21 11:47
- Which GMR to plug in BE-proff 2017-02-21 11:35
- Validated frameworks; observed GMR not relevant Helmut 2017-02-22 12:03
- Validated frameworks; observed GMR not relevant Silva 2017-03-09 01:26
- GMR, theta 0 and that alld_labes 2017-03-09 09:21
- GMR, theta 0 and that all Silva 2017-03-09 12:38
- GMR, theta 0 and that all ElMaestro 2017-03-09 12:56
- GMR, theta0 and that all d_labes 2017-03-09 13:55
- GMR, theta0 and that all Silva 2017-03-09 18:01
- GMR, theta 0 and that all Silva 2017-03-09 12:38
- GMR, theta 0 and that alld_labes 2017-03-09 09:21
- Validated frameworks; observed GMR not relevant Silva 2017-03-09 01:26
- Which GMR to plug in ElMaestro 2017-02-20 11:46
- Terminology Yura 2017-02-20 11:28
- Terminology Helmut 2017-02-18 16:27
- “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-21 11:31
- “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-18 13:31
- Data for 2nd stage of Potvin’s designs ElMaestro 2017-02-18 10:20