Bioequivalence and Bioavailability Forum

Pilot or pivotal ? [General Statistics]

posted by Ohlbe – France, 2018-06-27 17:43 (2569 d 10:22 ago) – Posting: # 18981
Views: 16,403

Hi ElMaestro,

❝ This is purely hypothetical for me. As far as I recall, I have not ever faced such a situation where two test formulations targeting the same authority were heads-on compared in a pivotal trial. I have faced it numerous times in pilot trials, but here the choice of formulation rarely is based on the CI but just on the observed GMR.

Precisely. But then, isn't this whole discussion on alpha correction purely hypothetical too ?

Sorry if I'm spoiling a nice thread...

—
Regards
Ohlbe

Complete thread:

Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00 [General Statistics]
- Two tests and one reference Helmut 2018-06-26 13:13
  - Two tests and one reference Brus 2020-08-31 09:58
    - Two tests and one reference ElMaestro 2020-08-31 10:23
    - Two regions: No α adjustment Helmut 2020-08-31 10:26
      - Two regions: No α adjustment Brus 2020-08-31 11:09
        
        Two regions: different populations Helmut 2020-08-31 11:26
- Decision of confidence interval of three period BE study ElMaestro 2018-06-26 22:20
  - Any of two tests and one reference Helmut 2018-06-27 00:33
    - Any of two tests and one reference libaiyi 2018-06-27 08:25
    - Hey wait a moment.... ElMaestro 2018-06-27 08:29
      - Hey wait a moment.... Helmut 2018-06-27 11:45
        
        Pilot or pivotal ? Ohlbe 2018-06-27 12:14
        
        Pilot or pivotal ? ElMaestro 2018-06-27 13:01
        
        Pilot or pivotal ? Ohlbe 2018-06-27 14:13
        
        Pilot or pivotal ? ElMaestro 2018-06-27 14:48
        
        Pilot or pivotal ?Ohlbe 2018-06-27 15:43
        
        Pilot or pivotal ? ElMaestro 2018-06-27 22:13
        
        Pilot or pivotal ? jag009 2018-06-29 20:53
        
        Pilot or pivotal ? ElMaestro 2018-06-29 22:11
        
        Pilot or pivotal ? jag009 2018-07-03 17:38
        
        Hey, hey wait another moment.... d_labes 2018-06-28 19:48
        
        Hey, hey wait another moment.... Helmut 2018-07-03 17:22
        
        Old belives die hard d_labes 2018-07-04 13:28

Pilot or pivotal ? [General Sta­tis­tics]

Complete thread:

Pilot or pivotal ? [General Statistics]