Bioequivalence and Bioavailability Forum • Median tmax

Median tmax [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-02-19 22:18 (4864 d 00:19 ago) – Posting: # 10069
Views: 10,472

Hi Helmut,

❝ Ask them

❝ • Why they refer to the mean although the guidance states the median?

❝ • Mean t_max of what?

Oh they did write "2 x mean Tmax of reference".

❝ ❝ I asked them and they said they have been using it with no issue.

❝ Absence of evidence ≠ evidence of absence. Indians claim a lot.

Either that or they don't answer or they said "we can change it". I can see that if it's not a guidance requirement, but they should adhere to the guidance when the sponsor said it's for FDA ANDA…

John

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 tmaxjag009 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