药物临床研究阶段申办者和生产场地变更研究二：欧盟药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示
王宏扬, 陈江鹏, 顾瑶华, 芦臣书, 夏雨, 连志荣, 吴正宇
Research Ⅱ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs: The Enlightenment of EU Requirements for Drug Clinical Trials and Change Management during Clinical Trials on Improving China's Regulatory System
Wang Hongyang, Chen Jiangpeng, Gu Yaohua, Lu Chenshu, Xia Yu, Lian Zhirong, Wu Zhengyu
中国药事
.
2024, (5): 499
-507
.
DOI: 10.16153/j.1002-7777.2024.05.002
