Bioequivalence and Bioavailability Forum • SOPitis

SOPitis [Design Issues]

posted by ElMaestro – Denmark, 2014-02-26 18:10 (4500 d 17:03 ago) – Posting: # 12516
Views: 7,040

Hi Hötzi,

❝ Write a macro in SAS which loops until balance is obtained. Write an SOP. Get many signatures (aka dissipation of responsibilities).

❝ Or would you prefer to push the button once and end up with all females in sequence RT and the males in TR? :pirate:

Yah, it is a borderline case.
I think I would word the protocol and study title carefully. The study is not really randomised if some randomisations are better than others. This is when I think stratification must be part of the wording.

For Xovers I wouldn't normally have a worry as long as we talk non-Brazilian and non-Japanese submissions. For parallel studies I might be inclined to stratify formally if two genders are necessary.

—
Pass or fail!
ElMaestro

Complete thread:

Randomization procedure with gender stratification Silva 2014-02-26 12:27
- 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
        
        SOPitisElMaestro 2014-02-26 17:10
        
        SOPitis mittyri 2014-02-26 19:23
        
        SOPitis ElMaestro 2014-02-26 22:31