摘要
以我国生物等效性研究相关指导原则为主要依据,参考国际监管机构相关要求,旨在从科学、伦理及审评的角度,以细胞毒、小分子靶向类口服抗肿瘤药为例,对口服抗肿瘤仿制药生物等效性研究考虑要点进行综述。
This paper takes the guidelines on bioequivalence study in China as the main basis,refers to the relevant requirements of international regulatory agencies,and takes the cytotoxic and small molecule targeted oral antitumor drugs as examples to give some considerations for the study design of bioequivalence of oral antitumor generics from the perspectives of science,ethics and review.
作者
刘霏霏
杨进波
王玉珠
LIU Fei-fei;YANG Jin-bo;WANG Yu-zhu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2021年第10期886-892,共7页
Chinese Journal of New Drugs
基金
国家“重大新药创制”科技重大专项资助项目(2017ZX09101001)。
关键词
抗肿瘤药
仿制药
生物等效性研究
试验设计
antitumor drug
generic drug
bioequivalence study
experimental design
