新药临床试验期间药物警戒和风险控制研究四:临床试验期间安全性定期报告监管要求研究
冯红云, 智会静, 李浩, 周凌芸, 邵颖, 吕心欢, 杨建红
Research IV on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: A Study on Regulatory Requirements for Periodic Safety Report in Clinical Trials
Feng Hongyun, Zhi Huijing, Li Hao, Zhou Lingyun, Shao Ying, Lü Xinhuan, Yang Jianhong
中国药事
.
2022, (6): 637
-643
.
DOI: 10.16153/j.1002-7777.2022.06.006