| Ⅰ期临床试验设计和需要重视的问题 |
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| 引用本文： | 钱薇,肖大伟.Ⅰ期临床试验设计和需要重视的问题[J].中国临床药理学与治疗学,2013,18(6):654-660. |
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| 作者姓名： | 钱薇 肖大伟 |
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| 作者单位： | 南京大学医学院附属鼓楼医院Ⅰ期临床试验研究室,南京210008,江苏 |
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| 摘 要： | Ⅰ期临床试验,特别是首次人类药物试验(First in human,FIH)具有极大的挑战性.在国外,试验设计方面近年来取得了很大进展.本文就Ⅰ期临床试验设计的技术、首剂量、安慰剂对照、剂量推升方案、终止标准和风险评估进行探讨.
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| 关 键 词： | Ⅰ期临床试验 首次人类试验 试验方案设计 风险评估 |
Phase Ⅰ clinical trial design and the problems need to focus |
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| QIAN Wei,XIAO Da-wei.Phase Ⅰ clinical trial design and the problems need to focus[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2013,18(6):654-660. |
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| Authors: | QIAN Wei XIAO Da-wei |
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| Institution: | (Department of Phase Ⅰ Clinical Trials, Affiliated Nanjing Drum Tower Hospital of Nanjing U niversity Medical College, Nanjing 210008, Jiangsu, China) |
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| Abstract: | Phase Ⅰ clinical trials, especially the first in human trials（FIH）of drugs are with greatly challenging.There are many great progress in design technology abroad.The starting dose, placebo-controlled,increasing doses,the trail termination criteria and risk assessment involved in the Phase Ⅰ clinical trial were reviewed in this article. |
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| Keywords: | Phase Ⅰ clinical trials First inhuman Protocol design Assessment of risk |
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