Bioequivalence and Bioavailability Forum

Median tmax [Regulatives / Guidelines]

posted by luvblooms  – India, 2013-02-20 06:03 (4863 d 17:30 ago) – Posting: # 10073
Views: 10,389

Hi Helmut,

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

Ouch!!!

That Hurts!!

It's not only about India, we have done a couple of studies in EU and Canada and everywhere same word was used.

Now coming to your point "The median of tmax-values after the reference in the study – without the subject who vomited" Do you mean that we need to get blood samples from all the volunteers, mesaure the plama concentration, run the stats and then exclude the volunteer.



Will it be acceptable by EMEA or FDA? (Remember In principle any reason for exclusion is valid provided it is specified in the protocol and the decision to exclude is made before bioanalysis)

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 tmaxluvblooms 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