The new Good Clinical Practice-2020 in China: Views from ethical perspective.
作者信息
Yang Feng, Heng Jianfu, Li Kunyan, Wang Jing
机构信息
Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan 410008, China.
出版信息
Lancet Reg Health West Pac. 2021 Mar 2;8:100117. doi: 10.1016/j.lanwpc.2021.100117. eCollection 2021 Mar.
Abstract
摘要
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3
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Pharmacol Res. 2018 May;131:218-223. doi: 10.1016/j.phrs.2018.02.010. Epub 2018 Feb 11.
4
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5
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