Bioequivalence and Bioavailability Forum • Assumptions…

Assumptions… [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2019-09-09 16:09 (2470 d 04:44 ago) – Posting: # 20558
Views: 11,808

Hi Rocco,

see what I wrote above.
Since you have no idea about the new formulation you have to assume indeed that the variances of T and R are at least similar. If you don’t like this assumption, there are just two ways out:

Pilot study or
Adaptive Two-Stage Sequential design.

Even if you are wary and walk this road, you have to assume things. The CV and the T/R-ratio are estimates and therefore, uncertain. Relying on assumptions is part of the game. Only death is certain.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Input for CV when small first-in-man has been run Rocco_M 2019-09-03 18:45
- Geometric mean and CV Helmut 2019-09-05 14:05
  - Geometric mean and CV Rocco_M 2019-09-05 23:49
    - Geometric mean and CV Helmut 2019-09-06 00:15
      - Geometric mean and CV Rocco_M 2019-09-06 17:49
        
        Geometric mean and CV Helmut 2019-09-06 18:15
        
        Geometric mean and CV ElMaestro 2019-09-06 19:03
        
        Geometric mean and CV Helmut 2019-09-07 09:57
        
        Geometric mean and CV Rocco_M 2019-09-09 13:31
        
        Assumptions…Helmut 2019-09-09 14:09
        
        Assumptions… Rocco_M 2019-09-09 16:35
        
        Assumptions… Helmut 2019-09-09 17:19
        
        Assumptions… Rocco_M 2019-09-13 21:28
        
        t-test & Welch-test Helmut 2019-09-14 00:16
        
        sampleN.TOST and CI.BE Rocco_M 2019-09-17 22:02
        
        assumptions vs. realizations Helmut 2019-09-18 11:04