2016年第48号通告附件:儿科人群药物临床试验技术指导原则
发布人:admin | 发布时间:2016-03-08 03:29:22
英文缩写
AAP: American Academy of Pediatrics,美国儿科学会
CFDA: China Food and Drug Administration,国家食品药品监督管理总局
DMC: Data Monitoring Committee,数据监察委员会
DSMB: Data and Safety Monitoring Boards,数据和安全监察委员会
DSMC: Data and Safety Monitoring Committee,数据和安全监察委员会
ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,人用药品注册技术规范国际协调会
PK: Pharmacokinetics,药代动力学
PD: Pharmacodynamics,药效学
参考文献
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