Bioequivalence and Bioavailability Forum • Sample size/power for PD BE study 3-way crossover

Sample size/power for PD BE study 3-way crossover [Power / Sample Size]

posted by jdetlor – 2011-04-01 18:56 (5556 d 12:29 ago) – Posting: # 6851
Views: 10,276

Hi ElMaestro!

❝ Absolutely. How would you specify the model here?

I maybe missing something here, but from my understanding, we are not working with a linear ANOVA model in terms of a cross-over analysis, but with the Emax model and estimating the 'f' parameter or the bioavailability (see the orlistat FDA individual guidance).

The cross-over design is used because it would still maintain balance within periods across treatments.

Edit: Guidance linked. [Helmut]

Complete thread:

Sample size/power for PD BE study 3-way crossover Coja66 2011-03-28 14:22
- Sample size/power for PD BE study 3-way crossover Helmut 2011-03-29 14:34
  - Sample size/power for PD BE study 3-way crossover Coja66 2011-03-29 15:31
    - Sample size/power for PD BE study 3-way crossover Dr_Dan 2011-03-30 10:13
      - Sample size/power for PD BE study 3-way crossover Coja66 2011-03-30 11:36
        
        Sample size/power for PD BE study 3-way crossover ElMaestro 2011-03-30 13:48
        
        Off topic (W.H.) Helmut 2011-03-30 13:59
        
        Off topic (W.H.) ElMaestro 2011-03-30 14:54
        
        Off topic (W.H.) Helmut 2011-03-30 15:05
        
        Sample size/power for PD BE study 3-way crossover ElMaestro 2011-03-31 19:55
        
        Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 15:52
        
        Sample size/power for PD BE study 3-way crossover ElMaestro 2011-04-01 16:19
        
        Sample size/power for PD BE study 3-way crossoverjdetlor 2011-04-01 16:56
        
        Sample size/power for PD BE study 3-way crossover ElMaestro 2011-04-01 17:14
        
        Sample size/power for PD BE study 3-way crossover jdetlor 2011-04-01 21:51