Bioequivalence and Bioavailability Forum • To whom it may concern

To whom it may concern [Two-Stage / GS Designs]

posted by d_labes – Berlin, Germany, 2016-03-07 12:41 (3765 d 08:55 ago) – Posting: # 16064
Views: 13,012

Dear ElMaestro,

you are totally right IMHO.
The reason why statisticians (some of) are accepting simulations only for type II error are the different roles of power and type I error.

Ideal statistical tests meet the rule that type I error is <=0.05 or some other threshold agreed upon. Using simulations to determine this has the drawback that you only can show this for the scenarios you have simulated. Not for the general case. Therefore a proof assuring no alpha-inflation is preferred.

Power on the other hand is useful for planning purposes (only). No strict criterion has to be applied to this term in general.

—
Regards,

Detlew

Complete thread:

The EMA’s BSWP’s opinon Helmut 2016-03-04 15:37 [Two-Stage / GS Designs]
- The EMA’s BSWP’s opinon ElMaestro 2016-03-04 23:16
  - Control of the TIE (empiric via simulations vs. proof) Helmut 2016-03-05 15:17
    - To whom it may concern ElMaestro 2016-03-06 22:59
      - To whom it may concernd_labes 2016-03-07 11:41
- Opinon? d_labes 2016-03-06 13:31
  - Obsession? Helmut 2016-03-06 14:45
    - Obsession? DavidManteigas 2016-06-02 12:57
      - 0.0501 not acceptable Helmut 2016-06-02 13:30
        
        OT: Guernsey McPearson's Drug Development Dictionary d_labes 2016-06-02 14:44
        
        OT: Comparison Helmut 2016-06-02 15:59
        
        OT: Comparison d_labes 2016-06-02 16:42