Bioequivalence and Bioavailability Forum

cortisol suppression as clinical endpoint [Design Issues]

posted by nobody – 2014-09-12 18:00 (4300 d 11:40 ago) – Posting: # 13500
Views: 14,014

...on the other hand: Teva and others succeeded with BE data alone apparently, got some Risk Management Plan with suppression to be studied, iirc the Assessment Report. So apparently not really needed, this fancy cortisol thing.

Complete thread:

• cortisol suppression as clinical endpoint lizhao 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 endpointnobody 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