[關(guān)鍵詞]
[摘要]
FDA在2012年公布了“藥物相互作用——研究設(shè)計、資料分析、對給藥的影響和對說明書的建議”的指導(dǎo)原則(草案)。介紹其中的Ⅱ指導(dǎo)原則摘要和Ⅵ對說明書的建議兩部分,希望對我國藥物相互作用研究和說明書撰寫有益。
[Key word]
[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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