Bioequivalence and Bioavailability Forum • Median tmax

Median tmax [Regulatives / Guidelines]

posted by intuitivepharma – India, 2013-02-28 14:05 (4856 d 05:38 ago) – Posting: # 10130
Views: 9,971

Dear Helmut,

Can I use median T_max data of reference formulation from my Pilot BE study in pivotal BE study to define the emesis withdrawal criteria? If yes, in case I have 3 pilots studies data, should the data be pooled or data from a single study with a higher sample size be preferred to calculate median T_max.

Thanks,
IP.

—
Thanks & Regards,
IP.

Complete thread:

FDA dropout guideline for Emesis jag009 2013-02-19 16:16 [Regulatives / Guidelines]
- Median tmax Helmut 2013-02-19 17:49
  - Median tmax jag009 2013-02-19 19:49
    - Median tmax Helmut 2013-02-19 20:28
      - Median tmax jag009 2013-02-19 21:18
        
        Intellectual horsepower Helmut 2013-02-19 21:49
        
        Intellectual horsepower jag009 2013-02-19 22:45
        Intellectual horsepower jag009 2013-02-20 16:12
        
        Intellectual horsepower Helmut 2013-02-20 17:03
        
        Intellectual horsepower jag009 2013-02-20 22:05
      - Median tmax luvblooms 2013-02-20 05:03
        
        Sorry for the overgeneralization Helmut 2013-02-20 16:54
        
        overgeneralization ???? luvblooms 2013-02-21 05:23
        
        overgeneralization ???? Helmut 2013-02-21 12:17
        overgeneralization ???? jag009 2013-02-21 16:55
  - Median tmaxintuitivepharma 2013-02-28 13:05
    - Median tmax from pilot studies Helmut 2013-02-28 14:02