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[摘要]
FDA在2012年公布了“药物相互作用——研究设计、资料分析、对给药的影响和对说明书的建议”的指导原则(草案)。介绍其中的Ⅱ指导原则摘要和Ⅵ对说明书的建议两部分,希望对我国药物相互作用研究和说明书撰写有益。
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[Abstract]
FDA announced “Guidance for Industry Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (draft)” in 2012. This article introduces Ⅱ summary of guidance and Ⅵ labeling recommendations thereof and it is beneficial to the studies and labeling writing of drug interaction in our country.
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