Bioequivalence and Bioavailability Forum • Potvin C consequences

Potvin C consequences [Two-Stage / GS Designs]

posted by mittyri – Russia, 2022-06-26 01:29 (1090 d 23:00 ago) – Posting: # 23087
Views: 4,800

Hi Helmut (and ElMaestro - sorry to post in this thread, but all your answers are great!),

❝ Of course, ElMaestro is right.

❝

There Can Be Only One.

OK, I understand the logic here.
take a look at some (theoretical) situation: a Sponsor goes with Potvin C (don't ask me why), moreover, he proved that with the current CV and n1 T1E does not exceed 5%.
But as you showed in the lectures and in example above, Potvin C could not ensure 5% for all combinations. Thus, during stage 1 the CV was lower and the resulted T1E was out of 5%.
What would be the right (safe) way out in such situation?

—
Kind regards,
Mittyri

Complete thread:

T1E after 1st stage in Power2Stage mittyri 2022-06-24 13:43
- T1E after 1st stage in TSDs Helmut 2022-06-24 14:33
  - T1E after 1st stage in TSDs mittyri 2022-06-24 21:12
    - T1E after 1st stage in TSDs Helmut 2022-06-25 14:07
      - Potvin C consequencesmittyri 2022-06-25 23:29
        
        Potvin C consequences ElMaestro 2022-06-26 09:11
        
        Potvin C consequences mittyri 2022-06-27 13:45
        
        Potvin C consequences Helmut 2022-06-27 14:49
        
        from Potvin C to Inverse Normal mittyri 2022-06-27 17:13
        
        From Potvin C to Inverse Normal: history (and outlook?) Helmut 2022-06-27 18:54
        
        Potvin C consequences ElMaestro 2022-06-27 17:13
        
        true CV ≠ observed CV mittyri 2022-06-27 17:22
- T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 18:25
  - T1E after 1st stage in Power2Stage mittyri 2022-06-24 21:05
    - T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 22:55