cortisol suppression as clinical endpoint [Design Issues]

posted by lizhao – US, 2014-09-11 01:21 (3487 d 00:18 ago) – Posting: # 13478
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Hi

I am study bioequivalence testing of inhaled corticosteriods using cortisol suppression as the metric. I just want to know what would be the study design suggested by EMA. Since there is cortisol is an endo­ge­nous compound in human body, the baseline needs to be substracted from post-treatment AUC of cortisol.

I can think of two kinds of study designs:
  1. baseline1 → Test treatment → washout period → baseline2 → Reference treatment

  2. baseline → Test treatment → Reference treatment
Can somebody tell me which one is the right one? If either one is correct, can you please tell me the study design recommended by EMA or FDA?

Thanks


Edit: Category changed. [Helmut]

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