Bioequivalence and Bioavailability Forum • Simulate 5x5x5 cross-over?

Simulate 5x5x5 cross-over? [Design Issues]

posted by ElMaestro – Denmark, 2013-01-31 18:13 (4898 d 11:31 ago) – Posting: # 9937
Views: 7,902

Hi John,

❝ I spoke with my past colleagues and he suggested something similar to what you said but instead of using T/R ratio, he said I can go ahead with using AUC and Cmax. Since I have the intrasubject CV from the reference datasets. I should apply this error to the generation of the 2nd test datasets (to generate AUC, Cmax) from the one test dataset as a starting pt for the 1st simulation. I can vary the intrasubject CVs to generate more scenarios.

❝

❝ ie: take Subject 1 data, sample from normal distribution randomly with mean 0, SD= Withinsubject standard deviation. Do the same for subject 2....

❝

❝ Is this similar to what you described?

I am not sure I follow completely, but by and large this sounds correct, although I would probably prefer to simulate all values (both Test and Ref) rather than just re-using those values you had in the previous study. Both approaches could be informative.
I don't know how to simulate directly on the T/R for a repliacted study, so I also agree that it should be done for AUC (or Cmax) for each subject and treatment, observing the desired T/R through the relation between the fixed treatment effects. That part is not so hard.

—
Pass or fail!
ElMaestro

Complete thread:

# of sequence for higher order crossover design jag009 2013-01-28 16:01
- # of sequence for 5-tmt-5period design d_labes 2013-01-28 16:37
  - # of sequence for 5-tmt-5period design jag009 2013-01-28 17:18
  - # of sequence for 5-tmt-5period design jag009 2013-01-29 15:12
    - Simulate 5x5x5 cross-over? d_labes 2013-01-29 15:28
      - Simulate 5x5x5 cross-over? jag009 2013-01-29 16:04
        
        Simulate a full replicate study d_labes 2013-01-29 16:52
        
        Simulate a full replicate study jag009 2013-01-29 17:00
        
        Simulate 5x5x5 cross-over? ElMaestro 2013-01-30 10:10
        
        Simulate 5x5x5 cross-over? jag009 2013-01-31 15:31
        
        Simulate 5x5x5 cross-over?ElMaestro 2013-01-31 17:13
        
        Simulate 5x5x5 cross-over? jag009 2013-02-01 15:33
        
        Simulate 5x5x5 cross-over? ElMaestro 2013-02-01 16:50
        
        Simulate 5x5x5 cross-over? jag009 2013-02-01 20:36
        
        Simulate 5x5x5 cross-over? ElMaestro 2013-02-02 02:21
        
        Simulate 5x5x5 cross-over? jag009 2013-02-04 15:06
        
        Sokme? d_labes 2013-02-04 09:05
        
        Some ElMaestro 2013-02-04 11:16