Online Program

Innovative Sampling and Analysis Techniques in Bioequivalence Study (301188)

Thomas Jaki, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK 
Helmut Schütz, 2. BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Vienna, Austria 
*Martin J. Wolfsegger, 1. Baxalta Innovations GmbH, a Takeda company, Vienna, Austria 

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.