Bioequivalence and Bioavailability Forum • Simulate a full replicate study

Simulate a full replicate study [Design Issues]

posted by d_labes – Berlin, Germany, 2013-01-29 17:52 (4890 d 15:47 ago) – Posting: # 9927
Views: 7,882

Hi John,

❝ In a nutshell here is what I am trying to do. I have a set of data from a parital 3-way replicate study (1 Test, reference given twice). I want to find out what happens if I simulate this to a full replicate study. Therefore I need to

❝ 1) Generating a 2nd set of data for the test product

❝ 2) I also want to introduce some intrasubject CVs on the test data

❝

❝ Question 1 can be done with bootstrap on the existing data(Correct?).

May be. I'm not quite sure. Depends on the goal of your simulations I think.

❝ But how should I approach question 2 so that I can see BE/SABE scenarios with different intrasubject CV on the test?

Simulating replicate studies is beyond the capacity of my brain.

—
Regards,

Detlew

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
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      - Simulate 5x5x5 cross-over? jag009 2013-01-29 16:04
        
        Simulate a full replicate studyd_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