新药临床试验期间药物警戒和风险控制研究三:药物临床试验期间个例安全性报告监管要求研究
冯红云, 周凌芸, 李浩, 邵颖, 吕心欢, 杨建红, 左晓春
Research III on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: On Regulatory Requirements for Individual Case Safety Reports in Clinical Trials of Drugs
Feng Hongyun, Zhou Lingyun, Li Hao, Shao Ying, Lü Xinhuan, Yang Jianhong, Zuo Xiaochun
中国药事
.
2022, (6): 630
-636
.
DOI: 10.16153/j.1002-7777.2022.06.005