Pharmacokinetics as a Biomarker

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Authors: John A. Wagner, Sonal Singh, Zachary L. Taylor
Cited by: 2
References: 5

Abstract

Pharmacokinetics (PK) has long been differentiated from pharmacodynamics (PD) and biomarkers, yet this distinction undervalues PK's translational relevance. In this Perspective, we propose that PK itself functions as a biomarker that bridges dose, exposure, and response. Using examples from target-mediated drug disposition, antidrug antibodies, cerebrospinal fluid PK, high-dose methotrexate therapy, and anti-infective pharmacology, we illustrate how PK serves as a measurable, predictive, and actionable biomarker that informs drug development, guides decisions, and advances precision medicine.

Fields of Study & Subjects

Monoclonal and Polyclonal Antibodies Research Multiple Sclerosis Research Studies Biosimilars and Bioanalytical Methods

Publication details

Journal / source
Clinical and Translational Science
Publisher
Wiley
Volume
19
Issue
2
Pages
e70486–e70486
Publication date
27 January 2026
Language
EN