PHARMACOKINETICS AND PHARMACODYNAMICS OF BIOLOGICS: WHAT CLINICIANS NEED TO KNOW

G. Pradeeptha Reddy*, Gudikal Mehatab Anjum, Goula Prathyusha, U. Abhilash Gupta, Angati Jaya Prasanna and Gopavarapu Chandra Sekhar Sai

ABSTRACT

Biologics, including monoclonal antibodies, fusion proteins, and other therapeutic proteins, have transformed modern medicine, offering highly targeted treatment options for a variety of diseases. Understanding their pharmacokinetics (PK) and pharmacodynamics (PD) is critical for optimizing clinical outcomes. This review highlights key concepts and considerations in the PK and PD of biologics, including absorption, distribution, metabolism, excretion (ADME), target-mediated drug disposition (TMDD), immunogenicity, and dose-response relationships. It also explores implications for dosing regimens, therapeutic drug monitoring (TDM), and the management of adverse effects.

Keywords: Biologics, Pharmacokinetics (PK), Pharmacodynamics (PD), Absorption, Distribution, Metabolism, Excretion (ADME), Target-mediated drug disposition (TMDD), Immunogenicity, Therapeutic drug monitoring (TDM), Monoclonal antibodies, Fusion proteins.