[關(guān)鍵詞]
[摘要]
FDA在2012年公布了“藥物相互作用——研究設(shè)計(jì)、資料分析、對(duì)給藥的影響和對(duì)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(duì)說明書的建議兩部分,希望對(duì)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.
[中圖分類號(hào)]
[基金項(xiàng)目]