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Registercortisol suppression as clinical endpoint [Design Issues]
Dear all,
what I am doing right now is using population based clinical trial simulations to prove that cortisol suppression is not a good clinical endpoint to show systemic bioequivalence.
My simulator could simulate crossover BE trials including both PK profiles and the corresponding cortisol profiles. Right now, based one the simulation results, even if I set Test and Reference products to be exactly the same, the probability of passing BE using cortisol suppression as a clinical endpoint is still very low.
I do need your guys' input so I am confident that I am doing the bioequilvance test in the right way.
My questions are 1: when compare cortisol suppression profiles of Test and Reference products, should I compare directly the cortisol suppression profiles of these products, or I have to do the "dose-scale" approach. Which means translate cortisol suppression back onto PK scale using dose-response curve?
2. What doses are usually being used for conducting cortisol suppression? ED50?
Thanks!!!!
Li
what I am doing right now is using population based clinical trial simulations to prove that cortisol suppression is not a good clinical endpoint to show systemic bioequivalence.
My simulator could simulate crossover BE trials including both PK profiles and the corresponding cortisol profiles. Right now, based one the simulation results, even if I set Test and Reference products to be exactly the same, the probability of passing BE using cortisol suppression as a clinical endpoint is still very low.
I do need your guys' input so I am confident that I am doing the bioequilvance test in the right way.
My questions are 1: when compare cortisol suppression profiles of Test and Reference products, should I compare directly the cortisol suppression profiles of these products, or I have to do the "dose-scale" approach. Which means translate cortisol suppression back onto PK scale using dose-response curve?
2. What doses are usually being used for conducting cortisol suppression? ED50?
Thanks!!!!
Li
Complete thread:
- cortisol suppression as clinical endpoint lizhao 2014-09-10 23:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 endpointlizhao 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
Ing. Helmut Schütz