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.
Agoram
Balaji M
BM
Pfizer, Department of Pharmacokinetics, Dynamics, and Metabolism (PDM), Sandwich CT13 NJ, UK.
Martin
Steven W
SW
van der Graaf
Piet H
PH
D000818:Animals; D001688:Biological Products / Q000493:pharmacokinetics* / Q000494:pharmacology*; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D010600:Pharmacology; D012106:Research / Q000639:trends*
D001688:Biological Products