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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