Bioequivalence and Bioavailability Forum • If possible, yes.

If possible, yes. [Design Issues]

posted by Helmut – Vienna, Austria, 2014-02-26 14:34 (4508 d 05:41 ago) – Posting: # 12505
Views: 7,122

Hi Silva,

❝ Does it make any sense covering in the randomization procedure in SAS, gender stratification for BE studies?

If the sample size is sufficiently large, why not? I doesn’t hurt. If you don’t stratify – by stupid chance – you might end up with extremely imbalanced sequences within subgroups. That’s not desirable.

❝ 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?

I don’t think so. But you never know what may come into the mind of assessors. ;-)

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Helmut Schütz

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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
        
        SOPitis ElMaestro 2014-02-26 22:31