Abstract

Translational pharmacokinetics (PK) is crucial in bridging the gap between preclinical drug research and clinical application, providing essential insights into a drug's absorption, distribution, metabolism, and excretion (ADME). This article explores the importance of PK in drug development, highlighting the transition from laboratory studies to clinical practice. Key stages in this transition include preclinical PK studies, scaling and modeling, first-in-human studies, and extensive clinical trials. The case study of Infliximab, a monoclonal antibody used to treat chronic inflammatory diseases, illustrates the application of translational PK. Despite challenges such as inter-species differences and biological complexity, advancements in modeling techniques and personalized medicine hold promise for improving drug development and patient care.