Rekić Dinko, Reynolds Kellie S, Zhao Ping, Zhang Lei, Yoshida Kenta, Sachar Madhav, Piquette Miller Micheline, Huang Shiew-Mei, Zineh Issam
AstraZeneca R&D, Gothenburg, Sweden.
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):2214-2218. doi: 10.1016/j.xphs.2017.04.016. Epub 2017 Apr 21.
Clinical drug-drug interactions (DDIs) can occur when multiple drugs are taken by the same patient. Significant DDIs can result in clinical toxicity or treatment failure. Therefore, DDI assessment is an integral part of drug development and the benefit-risk assessment of new therapies. Regulatory agencies including the Food and Drug Administration, the European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency of Japan have made recommendations in their DDI guidance documents on various methodologies (in vitro, in silico, and clinical) to assess DDI potential and inform patient management strategies. This commentary focuses on clinical DDI evaluation for the purpose of drug development and regulatory evaluation.
当同一患者服用多种药物时，可能会发生临床药物相互作用（DDI）。严重的药物相互作用可能导致临床毒性或治疗失败。因此，药物相互作用评估是药物研发以及新疗法获益风险评估不可或缺的一部分。包括美国食品药品监督管理局、欧洲药品管理局和日本药品与医疗器械局在内的监管机构，已在其药物相互作用指导文件中就评估药物相互作用可能性并为患者管理策略提供依据的各种方法（体外、计算机模拟和临床方法）提出了建议。本评论重点关注用于药物研发和监管评估目的的临床药物相互作用评估。
