| 论完善我国人体药物试验法律制度的几个问题 |
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| 引用本文： | 曹永高. 论完善我国人体药物试验法律制度的几个问题[J]. 法律与医学杂志, 2006, 13(4): 276-279 |
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| 作者姓名： | 曹永高 |
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| 作者单位： | 南京大学法学院 210093 |
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| 摘 要： | 药物人体试验是任何药品进入临床所必须经历的验证过程,其对于研究新药具有重要意义。然而该过程本身却又是充满风险的,必须用法律对试验进行规范。本文讨论了我国药品试验法律制度的缺陷,重点在于如何完善我国的药物人体试验法律制度。
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| 关 键 词： | 药物试验 GCP 受试者 研究者 |
| 文章编号： | 1007-9297(2006)04-0276-04 |
| 修稿时间： | 2006-04-11 |
Suggestions for improvement of GCP in Clinical trial |
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| CAO Yong-gao,Nanjing university. Suggestions for improvement of GCP in Clinical trial[J]. The Journal of Law & Medicine, 2006, 13(4): 276-279 |
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| Authors: | CAO Yong-gao Nanjing university |
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| Affiliation: | CAO Yong-gao,Nanjing university,210093 |
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| Abstract: | Clinical trial is an essential process in new drug research and development, hoverer, the process is full of risks and dangerousness, and therefore, Clinical trial must be guided by GCP. The defect of law and regulations on Clinical trial in our country was discussed, suggestions for improvement was given. |
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| Keywords: | The drug clinical trial GCP Research Subject |
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