Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2010 Apr;87(4):497-503. doi: 10.1038/clpt.2009.308. Epub 2010 Mar 3.
Many intrinsic and extrinsic factors can affect an individual patient's drug exposure and response. The US Food and Drug Administration (FDA) has published a number of guidances that recommend how and when to evaluate these factors during drug development. The most recent FDA draft guidance on drug interactions provides advice for in vitro and in vivo drug interaction studies, including suggestions for study design, dosing strategies and analysis, and interpretation of data for medical product labels. The draft guidance updated the FDA's recommendations on the evaluation of important cytochrome P450 (CYP) enzyme- and transporter-based drug interactions during drug development.
许多内在和外在因素会影响个体患者的药物暴露和反应。美国食品和药物管理局（FDA）发布了多项指南，建议在药物开发过程中如何以及何时评估这些因素。最近关于药物相互作用的 FDA 草案指南为体外和体内药物相互作用研究提供了建议，包括研究设计、给药策略和分析以及药物标签数据解释的建议。该草案指南更新了 FDA 关于在药物开发过程中评估重要细胞色素 P450（CYP）酶和转运体为基础的药物相互作用的建议。
