cortisol suppression as clinical endpoint [Design Issues]
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:
Thanks
Edit: Category changed. [Helmut]
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
Thanks
Edit: Category changed. [Helmut]
Complete thread:
- cortisol suppression as clinical endpointlizhao 2014-09-10 23:21 [Design Issues]
- 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
- cortisol suppression as clinical endpoint lizhao 2015-11-12 11:07
- cortisol suppression as clinical endpoint nobody 2015-11-12 08:27
- cortisol suppression as clinical endpoint lizhao 2015-11-12 02:15
- cortisol suppression as clinical endpoint nobody 2014-09-12 16:00
- cortisol suppression as clinical endpoint ElMaestro 2014-09-12 14:56
- cortisol suppression as clinical endpoint nobody 2014-09-12 13:59
- cortisol suppression as clinical endpoint lizhao 2014-09-11 23:00