Bioequivalence and Bioavailability Forum • cortisol suppression as clinical endpoint

cortisol suppression as clinical endpoint [Design Issues]

posted by lizhao – US, 2014-09-11 01:21 (4302 d 12:17 ago) – Posting: # 13478
Views: 16,131

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:

baseline1 → Test treatment → washout period → baseline2 → Reference treatment
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]

Complete thread:

cortisol suppression as clinical endpointlizhao 2014-09-10 23:21
- cortisol suppression as clinical endpoint ElMaestro 2014-09-10 23:42
- cortisol suppression as clinical endpoint nobody 2014-09-11 08:45
  - cortisol suppression as clinical endpoint lizhao 2014-09-11 23:00
    - cortisol suppression as clinical endpoint nobody 2014-09-12 13:59
      - cortisol suppression as clinical endpoint ElMaestro 2014-09-12 14:56
        
        cortisol suppression as clinical endpoint nobody 2014-09-12 16:00
        
        cortisol suppression as clinical endpoint lizhao 2015-11-12 02:15
        
        cortisol suppression as clinical endpoint nobody 2015-11-12 08:27
        
        cortisol suppression as clinical endpoint lizhao 2015-11-12 11:07
        
        cortisol suppression as clinical endpoint nobody 2015-11-12 16:06
        cortisol suppression as clinical endpoint ElMaestro 2015-11-13 18:39
        
        cortisol suppression as clinical endpoint lizhao 2015-11-13 20:56
        cortisol suppression as clinical endpoint lizhao 2015-12-02 23:00