Bioequivalence and Bioavailability Forum

Redosing study… [Study As­sess­ment]

posted by luvblooms  – India, 2011-06-17 08:34 (5491 d 11:02 ago) – Posting: # 7144
Views: 13,111

Dear Dr. Dan

Now I will give you 2 new scenario if

1. The identified Volunteer shows totally opposite behavior then the main study?
E.g.: In main study T/R ratio was lets say 1500% and in re-dosing study it becomes 15%. In that condition what can one do??

this a case of abnormal volunteer behavior only but how to justify it?

2. If one/more that one control subjects behave as an outlier in re-dosing study???

Luv

P.S.: These conditions are normal (real life instances) for re-dosing study .

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