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 in vitro and in vivo 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, in vivo 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.
Acknowledgment
Authors would like to thank Dr. Rob Foti for reviewing the IVIVE section of the manuscript.
Disclosure statement
VML is co-founder and chairman of the board of PersoMedix AB, CEO and shareholder of HepaPredict AB, and discloses consultancy work for Enginzyme AB.