ABSTRACT

Translational biomarker pharmacokinetic/pharmacodynamic (PK/PD) modeling utilizes preclinical in vitro and in vivo data and employs mathematical and statistical models to describe and understand them [1]. The PK/PD models developed can then be used to refine preclinical experiments and extrapolate findings to the clinical setting. One key benefit to this approach is that it facilitates understanding of the often-complex interaction between time- and dose-dependent PK and PD.