药物临床研究阶段申办者和生产场地变更研究三:美国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
于冰, 吴正宇, 陈江鹏, 陈园, 王方敏
Research Ⅲ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs: The Enlightenment of the Requirements for Drug Clinical Trials and Change Management during Clinical Trials in the United States on Improving China's Regulatory System
Yu Bing, Wu Zhengyu, Chen Jiangpeng, Chen Yuan, Wang Fangmin
中国药事
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2024, (5): 508
-515
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DOI: 10.16153/j.1002-7777.2024.05.003