| 创新药研发中0期临床试验的相关问题探讨 |
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| 引用本文： | 杨志敏,孙涛,赵德恒. 创新药研发中0期临床试验的相关问题探讨[J]. 中国新药杂志, 2010, 0(9) |
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| 作者姓名： | 杨志敏 孙涛 赵德恒 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心; |
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| 摘 要： | 通过对近年来在创新药研发领域中出现的0期临床试验的产生背景、研究思路和方法等相关问题进行阐述和分析,说明不断借鉴先进国家和地区在创新药研发技术新成果的精华,将会使我国创新药研发能力提高得更快更稳健。
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| 关 键 词： | 创新性药物 临床试验 0期 微剂量 |
Related issues in phase 0 clinical trials in research and development of investigational new drugs |
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| YANG Zhi-min,SUN Tao,ZHAO De-heng. Related issues in phase 0 clinical trials in research and development of investigational new drugs[J]. Chinese Journal of New Drugs, 2010, 0(9) |
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| Authors: | YANG Zhi-min SUN Tao ZHAO De-heng |
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| Affiliation: | YANG Zhi-min,SUN Tao,ZHAO De-heng(Center for Drug Evaluation,State Food , Drug Administration,Beijing 100038,China) |
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| Abstract: | In this paper,phase 0 clinical trials were systemically described and analyzed based on the background,research thinking and methods in research and development of investigational new drugs.The new skills of international pharmaceutical companies could improve research and development of new drugs more rapidly and steadily. |
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| Keywords: | investigational new drug clinical trials phase 0 microdose |
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