Bioequivalence and Bioavailability Forum • SOPitis

SOPitis [Design Issues]

posted by ElMaestro – Denmark, 2014-02-26 23:31 (4090 d 17:16 ago) – Posting: # 12522
Views: 5,743

Hi Mittyri,

❝ Could you give an example of wording?

❝ "Multicentre, single-dose, randomised, open label, two-sequence, two-period, crossover, bioavailability study in male and female patients under fed conditions with gender stratification" - something like that?

Yes, or simply "Multicentre, single-dose, gender-stratified, randomised, open label, two-sequence, two-period, crossover, bioavailability study under fed conditions."

❝ Would stratification be applicable in BEQ studies from assessors point of view? Any experience?

I think so but I am hard pressed to think of a common situation where it would be really relevant.

—
Pass or fail!
ElMaestro

Complete thread:

Randomization procedure with gender stratification Silva 2014-02-26 12:27 [Design Issues]
- If possible, yes. Helmut 2014-02-26 13:34
  - If possible, yes. Silva 2014-02-26 13:41
    - Trial and error Helmut 2014-02-26 13:53
      - Trial and error Silva 2014-02-26 14:05
      - Trial and error ElMaestro 2014-02-26 14:45
        
        SOPitis Helmut 2014-02-26 14:52
        
        SOPitis ElMaestro 2014-02-26 17:10
        
        SOPitis mittyri 2014-02-26 19:23
        
        SOPitisElMaestro 2014-02-26 22:31