Bioequivalence and Bioavailability Forum • Input for CV when small first-in-man has been run

Input for CV when small first-in-man has been run [Power / Sample Size]

posted by Rocco_M – Mexico, 2019-09-03 20:45 (1860 d 17:46 ago) – Posting: # 20537
Views: 8,057

Hi all,

I have a question about initial input for CV into a sample size calculation comparing two formulations when all that has been run is a single study, say, a first in man. Since it is not correct to use sd/mean from the first formulation as your CV, but if it is all you have (say, you measured log(AUC) from ten patients for a single formulation (ie, only for the reference), what would you input as CV for a subsequent parallel (say) study between this formulation and another one not yet available) in order to estimate sample size?

I see people will typically enter sample sd / sample mean of the single formulation, but I feel this is incorrect.

Complete thread:

Input for CV when small first-in-man has been runRocco_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