Bioequivalence and Bioavailability Forum

Redosing study… [Study As­sess­ment]

posted by luvblooms  – India, 2011-06-17 14:50 (5078 d 07:24 ago) – Posting: # 7149
Views: 10,672

Dear EM

Well

❝ ❝ 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??

❝

❝ Reformulate

But that is not the problem of formulation as all others (65 volunteer out of 66) gave normal results in the range of 80-125% TR ratio (with min of 34% and max of 244%) and only one was acting weird.

If such is the case, even after reformulation same volunteer or someone of the same category could be there to kill your study!!

Then What??

Again reformulation

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