Bioequivalence and Bioavailability Forum

Guideline on bioanalytical method validation European Medicines Agency, 2011
stated "For bioequivalence studies, normally reanalysis of study samples because of a pharmacokinetic reason is not acceptable, as this may affect and bias the outcome of such a study. In this case, reanalysis might be considered as part of laboratory investigations, to identify possible reasons for results considered as abnormal and to prevent the recurrence of similar problems in the future.
In case of reanalysis because of positive pre-dose samples or because of a pharmacokinetic reason,the reanalysed samples should be identified and the initial value, the reason for reanalysis, the values obtained in the reanalyses, the finally accepted value and a justification for the acceptance should be provided."

In the light of this statement whether reanalysis on the basis of pharmacokinetic reason is acceptable? what would be the possible justification for accepting the reanalyzed (new) value?

Regards

Dr. N. Hashmi