Bioequivalence and Bioavailability Forum

Dear keyurkakkad
According to the guideline exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
The exceptions to this are:
1) A subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentrations if ist AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial.
2) Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation (see carry-over effects below).
In general it is not possible to exclude outliers even if they are statistically significant.
Kind regards
Dan