Bioequivalence and Bioavailability Forum • FDA dropout guideline for Emesis

FDA dropout guideline for Emesis [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-02-19 17:16 (4864 d 06:19 ago) – Posting: # 10061
Views: 11,786

Hi all,

For subjects who experience emesis post dose. The guideline stated emesis within 2x median Tmax. Can one use mean Tmax instead if the median value is not available?

Thanks
John

Complete thread:

FDA dropout guideline for Emesisjag009 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 studies Helmut 2013-02-28 14:02