加速创新型治疗用生物制品CMC 开发与注册的国内外法规现状与分析
吕香霖, 王雅英, 张小华, 陈明, 张林琦
Status and Analysis of Domestic and Foreign Laws and Regulations on Accelerated
CMC Development and Registration of Innovative Therapeutic Biological Products
LYU Xianglin, WANG Yaying, ZHANG Xiaohua, CHEN Ming , ZHANG Linqi
中国医药工业杂志
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2023, (06): 957
-964
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DOI: 10.16522/j.cnki.cjph.2023.06.018
