All Times EDT
Keywords: area under the concentration time curve; bioequivalence, non-compartmental; PK parameters; sparse sampling
In traditional BE analysis, the confidence interval inclusion principle is applied on the ratios of geometric means of the area under the concentration-time curves (AUC) and the maximal concentration (Cmax), derived from PK studies with rich sampling using the non-compartmental approach (NCA) to test for equivalence in those PK metrics. This standard approach is not feasible in the case of sparse sampling. This talk will address some challenges regarding establishing bioequivalence in incomplete sampling designs from a technical as well as regulatory point of view.