Abstract

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the clinical drug interaction studies-study design, data analysis, and clinical implications guidance for industry(draft guidance) in 2017.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. Key words: Drug interactions; Research design; Clinical trials; Guideline

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