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药物临床研究阶段申办者和生产场地变更研究一：日本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
吴正宇, 连志荣, 王宏扬, 李圆圆, 张小勇, 杨建红
中国药事 ›› 2024, Vol. 38 ›› Issue (5) : 491-498.
PDF(897 KB)
PDF(897 KB)
药物临床研究阶段申办者和生产场地变更研究一：日本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
({{custom_author.role_cn}}), {{javascript:window.custom_author_cn_index++;}}Research Ⅰ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs: The Enlightenment of Japanese Requirements for Drug Clinical Trials and Change Management during Clinical Trials on Improving China's Regulatory System
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