Bioequivalence and Bioavailability Forum • Median tmax from pilot studies

Median tmax from pilot studies [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-02-28 15:02 (4856 d 00:06 ago) – Posting: # 10132
Views: 10,100

Hi IP!

❝ 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?

Good idea! Doing so you can avoid the data-driven decision and state a cut-off already in the protocol.

❝ […] 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.

I would pool the data. Having more information can’t be bad.

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Helmut Schütz

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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 tmax intuitivepharma 2013-02-28 13:05
    - Median tmax from pilot studiesHelmut 2013-02-28 14:02