Bioequivalence and Bioavailability Forum • Assumptions…

Assumptions… [Power / Sample Size]

posted by Rocco_M – Mexico, 2019-09-09 18:35 (1684 d 12:07 ago) – Posting: # 20560
Views: 6,066

Gracias and sorry for confusion. Here is what I think I am not getting. When you run a FIM, you do not have two populations. You have a treatment and (perhaps) a control. So if you have a geometric CV, say, CV1 calculated from that one treatment sample in the FIM. [It is not pooled variance, is it? There is only one sample] there and then use it to design a parallel follow-up, do you need to assume that the CV of the other arm, call it CV2, is equal to CV1, and then CVp = pooled(CV1,CV2) as input into sample size formula, eg, sampleNTOST?

Much apology if I am missing this point. I do not seem to understand what are the components of the pooled variance that go into the sample size computation.

Complete thread:

Input for CV when small first-in-man has been run Rocco_M 2019-09-03 18:45 [Power / Sample Size]
- 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