《药品生产企业临床药物相互作用研究:试验设计、数据分析、临床应用指南(草稿)》解读

Interpretation of clinical drug interaction studies-study design, data analysis, and clinical implications guidance for industry(draft guidance)

2017年美国食品药品管理局药品审评和研究中心再次更新了《药品生产企业临床药物相互作用研究:试验设计、数据分析、临床应用指南(草稿)》(以下简称《指南》)。本文从新药进行药物相互作用研究的重要性、药物相互作用研究中的参比药物、针对临床预期合用药物的相互作用研究、前瞻性药物相互作用研究设计和注意事项、细胞色素P450介导的药物相互作用研究注意事项、药物转运蛋白相关药物相互作用研究注意事项、药物相互作用研究的其他注意事项及说明书中关于药物相互作用信息的表述等方面,对《指南》进行了解读,为临床合理用药提供参考。

Center for Drug Evaluation and Research of the Food and Drug Administration of the United States renewed the "clinical drug interaction studies-study design, data analysis, and clinical implications guidance for industry(draft guidance)" in 2017. In this paper, the importance of research on drug interaction of new drugs, reference drugs in research on drug interaction, research on interaction of anticipated clinical combination drugs, design and precautions of prospective research on drug interaction, research precautions of cytochrome P450-mediated drug interaction, research precautions of drug transporter-related drug interaction, other precautions on drug interaction research, description of drug interaction information in drug labels, and etc. were interpreted, so as to provide reference for rational drug use in clinical.