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Achievwin ★★ US, 2019-01-24 18:50 (2284 d 00:25 ago) Posting: # 19806 Views: 3,168 |
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In a BE study (two stage or one stage) are we allowed to have two primary objectives? Let us say either/or objective 1 or Objective 2 meets the BE criteria Bioequivalence is concluded. Does anyone have experience in OGD entertaining such statistical analysis plan? Thanks for your suggestions, AchievWin |
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ElMaestro ★★★ Denmark, 2019-01-25 10:55 (2283 d 08:20 ago) @ Achievwin Posting: # 19807 Views: 2,519 |
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Hi Achievwin, ❝ In a BE study (two stage or one stage) are we allowed to have two primary objectives? Let us say either/or objective 1 or Objective 2 meets the BE criteria Bioequivalence is concluded. ❝ ❝ Does anyone have experience in OGD entertaining such statistical analysis plan? It is often not a problem to have two objectives, and it is not entirely uncommon to have duality in the analysis but you may need to account for alpha inflation if this protocol allows you "two chances" to show BE. More details about your design and the nature of your objectives would be necessary before I would dare to come forward with a less vague opinion. For example, do you have two formulations and you hope to show BE for (at least) one of them? — Pass or fail! ElMaestro |
Ing. Helmut Schütz