Wagner John A, Singh Sonal, Taylor Zachary L
Aditum Bio, Tempero Bio, and Trames Bio, Cambridge, Massachusetts, USA.
Merck & Co., Inc., South San Francisco, California, USA.
Clin Transl Sci. 2026 Feb;19(2):e70486. doi: 10.1111/cts.70486.
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.
长期以来，药代动力学（PK）一直与药效学（PD）和生物标志物区分开来，但这种区分低估了PK的转化相关性。在本观点文章中，我们提出PK本身可作为连接剂量、暴露和反应的生物标志物。通过靶向介导的药物处置、抗药物抗体、脑脊液PK、高剂量甲氨蝶呤治疗以及抗感染药理学等方面的例子，我们阐述了PK如何作为一种可测量、可预测且可采取行动的生物标志物，为药物开发提供信息、指导决策并推动精准医学发展。
