| 实施创新药Ⅰ期临床试验中的问题与对策 |
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| 引用本文： | 李天萍,王永庆,张宏文,欧宁,梁宁霞,王虹,赵俊.实施创新药Ⅰ期临床试验中的问题与对策[J].中华医学科研管理杂志,2012,25(4):229-231. |
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| 作者姓名： | 李天萍 王永庆 张宏文 欧宁 梁宁霞 王虹 赵俊 |
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| 作者单位： | 210029,南京医科大学第一附属医院药物临床试验机构 |
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| 基金项目： | 科技部“重大新药创制”科技重大专项（2011ZX09302-00302） |
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| 摘 要： | 创新药的Ⅰ期临床试验是整个临床研究过程的关键环节.本研究重点阐述了南京医科大学第一附属医院在实施创新药Ⅰ期临床研究中的体会与经验.
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| 关 键 词： | 创新药 Ⅰ期临床试验 |
Issues and countermeasures for the conduct of phase Ⅰ clinical trial of new drugs |
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| LI Tian-ping
,
WANG Yong-qing
,
ZHANG Hong-wen
,
OU Ning
,
LIANG Ning-xia
,
WANG Hong
,
ZHAO Jun.Issues and countermeasures for the conduct of phase Ⅰ clinical trial of new drugs[J].Chinese Journal of Medical Science Research Management,2012,25(4):229-231. |
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| Authors: | LI Tian-ping WANG Yong-qing ZHANG Hong-wen OU Ning LIANG Ning-xia WANG Hong ZHAO Jun |
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| Institution: | . National Medical Institution Conducting Drug Clinical Trial of The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu Province, P. R. China |
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| Abstract: | Phase Ⅰ Clinical trial of new drugs is key for clinical drug development. In this article, we describe our experience and reflection on phase Ⅰ clinical trials of new drugs at the First Affiliated Hospital of Nanjing Medical University. |
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| Keywords: | New drugs PhaseⅠ clinical trials |
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