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中药新药非临床安全性研究和评价的思考

岑小波 韩玲

中国药理学与毒理学杂志2016,Vol.30Issue(12):1343-1358,16.
中国药理学与毒理学杂志2016,Vol.30Issue(12):1343-1358,16.DOI:10.3867/j.issn.1000-3002.2016.12.013

中药新药非临床安全性研究和评价的思考

Consideration on non-clinical safety evaluation of traditional Chinese medicine

岑小波 1韩玲2

作者信息

  • 1. 四川大学华西医院/临床医学院国家成都新药安全性评价中心,四川 成都 610041
  • 2. 国家食品药品监督管理总局药品审评中心,北京 100038
  • 折叠

摘要

Abstract

Safety,efficacy and quality control are the three essential elements for drugs,including traditional Chinese medicine(TCM). Currently,rapid development of life sciences,medicine and phar⁃macy provides new prospects for TCM. Considering the long history of TCM application,modern phar⁃ macology and toxicology, global standards and expectations on the safety of TCM, how to evaluate the safety of TCM scientifically has become a key to the research and development of TCM. This review aims to discuss current technical requirements of non-clinical safety study of TCM as well as the challenges.

关键词

非临床安全性评价/中药/毒性

Key words

non-clinical safety evaluation/traditional Chinese medicine/toxicity

分类

医药卫生

引用本文复制引用

岑小波,韩玲..中药新药非临床安全性研究和评价的思考[J].中国药理学与毒理学杂志,2016,30(12):1343-1358,16.

基金项目

国家科技重大专项(2012ZX09302-004)@@@@The project supported by National Science and Technology Major Project of China ()

中国药理学与毒理学杂志

OA北大核心CSCDCSTPCD

1000-3002

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