Galetin Aleksandra, Zhao Ping, Huang Shiew-Mei
Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
J Pharm Sci. 2017 Sep;106(9):2204-2208. doi: 10.1016/j.xphs.2017.03.036. Epub 2017 Apr 5.
Physiologically based pharmacokinetic modeling is a commonly used strategy in the drug development and regulatory submissions. This commentary provides a critical overview of the current status of physiologically based pharmacokinetic methodologies to predict transporter-mediated pharmacokinetics, in addition to the impact of disease and genetics with respect to local and systemic concentration.
基于生理学的药代动力学建模是药物研发和监管申报中常用的策略。本评论对基于生理学的药代动力学方法在预测转运体介导的药代动力学方面的现状进行了批判性综述,此外还探讨了疾病和遗传学对局部和全身浓度的影响。