Bioequivalence and Bioavailability Forum • I've meditated hard

I've meditated hard [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2017-11-14 13:41 (2682 d 10:16 ago) – Posting: # 17979
Views: 9,962

Hi Hötzi,

❝ 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).

Can you reformulate?
I meditated hard and I don't see why my suggestion does not address it. It will treat AUCt as if it having a higher CV for everything except BE evaluation. It is if I get your question correctly exactly what is going on.
So perhaps I did not understand you. While I sit in Lotus position and humming gently, do you think you could somehow put other words to the part I don't get?

—
Pass or fail!
ElMaestro

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
      - Nope Helmut 2017-11-14 00:21
        
        Nope nobody 2017-11-14 08:11
        I've meditated hardElMaestro 2017-11-14 12:41