The role of mechanism-based pharmacokinetic–pharmacodynamic (PK–PD) modelling in translational research of biologics

Lack of predictability of clinical efficacy and safety is an important problem facing pharmaceutical research today. Translational PK–PD has the ability to integrate data generated from diverse test platforms during discovery and development in a mechanistic framework. Therefore, successful implementation of translational PK–PD modelling and simulation early in the development cycle could have a substantial impact on overall efficiency and success of pharmaceutical research. Three case studies are presented, which outline successful implementation of the translational PK–PD methodology in the rational development of biotherapeutics across various stages of discovery and development. Emerging developments within the field are also discussed.