Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies.

Monoclonal antibodies (mAbs) are an important therapeutic class with complex pharmacology and interdependent pharmacokinetic (PK) and pharmacodynamics (PD) properties. Understanding the PK and PD of mAbs and their biological and mechanistic underpinnings are crucial in enabling their design and selection, designing appropriate efficacy and toxicity studies, translating PK/PD parameters to humans, and optimizing dose and regimen to maximize success in the clinic. Significant progress has been made in this field however many critical questions still remain. This article gives a brief overview of the PK and PD of mAbs, factors that influence them, and areas of ongoing inquiry. Current tools and translational approaches to predict the PK/PD of mAbs in humans are also discussed.