Recent developments in<i>in vitro</i>and<i>in vivo</i>models for improved translation of preclinical pharmacokinetics and pharmacodynamics data

Abstract

Improved pharmacokinetics/pharmacodynamics (PK/PD) prediction in the early stages of drug development is essential to inform lead optimization strategies and reduce attrition rates. Recently, there have been significant advancements in the development of new <i>in vitro</i> and <i>in vivo</i> strategies to better characterize pharmacokinetic properties and efficacy of drug leads. Herein, we review advances in experimental and mathematical models for clearance predictions, advancements in developing novel tools to capture slowly metabolized drugs, <i>in vivo</i> model developments to capture human etiology for supporting drug development, limitations and gaps in these efforts, and a perspective on the future in the field.