Bioequivalence and Bioavailability Forum

Redosing study… [Study As­sess­ment]

posted by luvblooms  – India, 2011-06-18 13:53 (5487 d 13:05 ago) – Posting: # 7154
Views: 13,003

Dear GS

❝ I will say theoretically it is not possible and practically it is possible only when the subject was in specific condition (vomit, under stress or anything) for one product in pivotal study and under same condition for another product in re-dosing study which means poor conduct of study.

Well, the gap between the study was more than 4 months and I am still not sure that in 4 months also his worries has not been solved (there were no vomiting) and also I am unable to understand the type of worry which completely change the GI behaviour in 4 months and that too in a formulation specific way.

❝ In place of going for re-dosing study, one can do an investigation and give solid clinical justification for such an outlying behavior with "statistical outlier test" confirming the value as an outlier.

But how to justify different behaviour at different time.

Luv

Complete thread:

• Redosing study… H.Patel 2011-06-15 16:28 
  • Redosing study… swapnil.kuche 2011-06-16 08:35
    • Redosing study… Dr_Dan 2011-06-16 12:37
      • Redosing study… Helmut 2011-06-16 12:52
      • Redosing study… GSTATS 2011-06-16 16:12
      • Redosing study… luvblooms 2011-06-17 06:34
        • Redosing study… ElMaestro 2011-06-17 09:16
          • Redosing study… luvblooms 2011-06-17 12:50
            • Redosing study… ElMaestro 2011-06-17 13:09
              • Redosing study… luvblooms 2011-06-18 11:47
            • Redosing study… GSTATS 2011-06-17 16:57
              • Redosing study…luvblooms 2011-06-18 11:53