Randomization procedure with gender strati­fication [Design Issues]

posted by Silva – Portugal, 2014-02-26 13:27 (3651 d 01:52 ago) – Posting: # 12502
Views: 5,350

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

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