Reflections on the Bridging Methods in the Early Exploratory General Toxicology Study

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	Reflections on the Bridging Methods in the Early Exploratory General Toxicology Study
	Liu Yongzhen; Gong Likun; Ren Jin
刊名	Chinese Pharmaceutical Journal
	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
内容类型	期刊论文
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.