Bioequivalence and Bioavailability Forum • Nope

Nope [Two-Stage / GS Designs]

posted by nobody – 2017-11-14 09:11 (3137 d 14:51 ago) – Posting: # 17978
Views: 12,762

IANAL, but I think what San-Diego-man is proposing is to calculate BE-outcome (pass/fail) after stage 1 and compare it to BE-outcome after the (unnecessary) second stage for, let's say, 1 gazillion of studies and see if there is a meaningful difference.

Isn't this a special example of the more general "forced BE" theme in one-stage designs?

—
Kindest regards, nobody

Complete thread:

Two PK metrics: Inflation of the Type I Error Helmut 2017-11-12 11:57
- Two PK metrics: Inflation of the Type I Error? d_labes 2017-11-12 17:46
- A place to start ElMaestro 2017-11-12 21:43
  - A place to start? d_labes 2017-11-13 16:02
    - A place to start? Helmut 2017-11-13 16:51
      - Scientific gut feeling d_labes 2017-11-15 10:34
        
        Five minutes gone - power.tsd.2m() arose d_labes 2017-11-15 13:15
    - A better place to start. ElMaestro 2017-11-14 00:04
      - Nope Helmut 2017-11-14 00:21
        
        Nopenobody 2017-11-14 08:11
        I've meditated hard ElMaestro 2017-11-14 12:41