Bioequivalence and Bioavailability Forum

Randomization procedure with gender stratification [Design Issues]

posted by Silva – Portugal, 2014-02-26 13:27 (4070 d 01:59 ago) – Posting: # 12502
Views: 6,678

Dear all

Does it make any sense covering in the randomization procedure in SAS, gender stratification for BE studies? Despite FDA refers that BE study data is not expected to have sufficient power to draw conclusions for each subgroup and therefore statistical analysis of subgroups is not recommended, do you think in a near future this may overcome?

Best regards
Silva

Complete thread:

Randomization procedure with gender stratificationSilva 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
        
        SOPitis ElMaestro 2014-02-26 22:31

Randomization procedure with gender strati­fication [Design Issues]

Complete thread:

Randomization procedure with gender stratification [Design Issues]