Bioequivalence and Bioavailability Forum • Sample size for PK linearity

Sample size for PK linearity [Power / Sample Size]

posted by Kro – France, 2009-05-19 12:56 (6236 d 22:33 ago) – Posting: # 3699
Views: 24,080

Hi,

I would like to estimate a sample size for a PK linearity study.
The study design plans to test 4 different doses (10, 20, 30 and 40).
I need to test the bioequivalence for each dose, compared to the reference dose which is 20. In addition I need to calculate the linear correlation slope for the four doses, a deviation of 20% between doses being acceptable.

What is the required methodology and what is the formula to calculate the sample size?

Regards,

Kro

Complete thread:

Sample size for PK linearityKro 2009-05-19 10:56 [Power / Sample Size]
- Sample size for PK linearity Helmut 2009-05-19 13:19
  - Sample size for PK linearity Kro 2009-05-19 13:56
    - Sample size for PK linearity Helmut 2009-05-19 15:09
      - Sample size for PK linearity ElMaestro 2009-05-26 17:26
        
        Weighting scheme Helmut 2009-05-26 19:52
      - Sample size for PK linearity mjons 2011-12-08 18:03
      - Sample size for PK linearity Lucas 2014-09-11 21:41
        
        Sample size for PK linearity - power model d_labes 2014-09-12 15:01
        
        Power dose proportionality - power model - Correction d_labes 2014-10-01 09:09
        
        Sample size for PK linearity d_labes 2014-09-13 15:05
        
        Sample size for PK linearity Lucas 2014-10-13 20:36
        
        Sample size for PK linearity d_labes 2014-10-14 09:26
        
        Sample size for PK linearity Lucas 2014-10-14 15:24
  - dose proportionality vs. dose linearity martin 2009-05-25 08:46
    - dose proportionality vs. dose linearity Helmut 2009-05-25 14:59