Bioequivalence and Bioavailability Forum • Nope

Nope [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2017-11-14 01:21 (2683 d 14:59 ago) – Posting: # 17977
Views: 10,035

Hi ElMaestro,

❝ Best I can come up with is as follows:

❝ The only thing that determines the need for for stage 2 is the CV. :blahblah:

❝

❝ So run the sims in the usual fashion, but add 5-20 points on the CV for the power and sample size estimation.

That’s not my point. Meditate over my example. We would initiate the second stage with 28 subjects (driven by the CV of C_max 0.30) but should stop after the first stage for AUC (CV 0.20).

—
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Helmut Schütz

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Complete thread:

Two PK metrics: Inflation of the Type I Error Helmut 2017-11-12 11:57 [Two-Stage / GS Designs]
- 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
      - NopeHelmut 2017-11-14 00:21
        
        Nope nobody 2017-11-14 08:11
        I've meditated hard ElMaestro 2017-11-14 12:41