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RegisterRedosing study… [Study Assessment]
posted by GSTATS 
– India, 2011-06-17 18:57 (5485 d 10:13 ago) – Posting: # 7152
Views: 12,985
Dear LB
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.
Even if in a re-dosing study, subject repeats its anomalous behavior then no one can save your study. OR 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.
Regards,
GSTATS
www.gstatsolutions.com
❝ ❝ ❝ 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?? 
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.
❝ 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??
Even if in a re-dosing study, subject repeats its anomalous behavior then no one can save your study. OR 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.
Regards,
GSTATS
www.gstatsolutions.com
—
Let Noble Thoughts come from Every Side: RIG VEDA
Let Noble Thoughts come from Every Side: RIG VEDA
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