中国科学院机构知识库网格
Chinese Academy of Sciences Institutional Repositories Grid
Reflections on the Bridging Methods in the Early Exploratory General Toxicology Study

文献类型:期刊论文

作者Liu Yongzhen; Gong Likun; Ren Jin
刊名Chinese Pharmaceutical Journal
出版日期2013
卷号48期号:21页码:1785-1788
关键词acute toxicity study maximum tolerated dose dose range finding study
ISSN号1001-2494
其他题名关于新药早期探索性-桥接性一般毒理学研究的思考
文献子类Article
英文摘要To discuss early exploratory bridging studies between early screening phase and pivotal general toxicology studies and their application during new drug development. METHODS The opinions on acute toxicity study from international counterparts and current application in domestic and overseas were briefly reviewed. At the same time, the study design and the strengths of an alternative maximum tolerated dose/dose range finding(MTD/DRF)study widely used abroad were fully discussed. Furthermore, considerations were also highlighted based on the authors' experience, which may aid in the design and the conduct of such bridging studies. RESULTS AND CONCLUSION MTD/DRF study could provide more valuable information for subsequent non-clinical regulatory toxicity studies. It is a rational and practical general toxicological study with bridging character.
资助项目国家重大新药创制科技重大专项课题[00000000]
WOS研究方向Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种中文
CSCD记录号CSCD:4992843
源URL[http://119.78.100.183/handle/2S10ELR8/269365]  
专题药物安全性评价中心
通讯作者Gong Likun; Ren Jin
作者单位Center for Drug Safety Evaluation and Research, State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
推荐引用方式
GB/T 7714
Liu Yongzhen,Gong Likun,Ren Jin. Reflections on the Bridging Methods in the Early Exploratory General Toxicology Study[J]. Chinese Pharmaceutical Journal,2013,48(21):1785-1788.
APA Liu Yongzhen,Gong Likun,&Ren Jin.(2013).Reflections on the Bridging Methods in the Early Exploratory General Toxicology Study.Chinese Pharmaceutical Journal,48(21),1785-1788.
MLA Liu Yongzhen,et al."Reflections on the Bridging Methods in the Early Exploratory General Toxicology Study".Chinese Pharmaceutical Journal 48.21(2013):1785-1788.

入库方式: OAI收割

来源:上海药物研究所

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