新药临床试验期间药物警戒和风险控制研究一:欧美新药临床试验期间药物警戒体系要求对我国申办者的启示
智会静, 冯红云, 周凌芸, 杨建红, 吕心欢, 黎泽琳, 李浩
中国药事 ›› 2022, Vol. 36 ›› Issue (6) : 616-623.
新药临床试验期间药物警戒和风险控制研究一:欧美新药临床试验期间药物警戒体系要求对我国申办者的启示
Research I on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: The Enlightenment of the Requirements for Pharmacovigilance System in Europe and US to Chinese Sponsors
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