| 加强过程监查，提高药物临床试验质量 |
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| 引用本文： | 宋苹,唐雪春,张勋.加强过程监查，提高药物临床试验质量[J].中国新药与临床杂志,2008,27(4):300-302. |
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| 作者姓名： | 宋苹 唐雪春 张勋 |
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| 作者单位： | 广东省中医院,广东,广州,510120 |
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| 摘 要： | 新药临床试验质量是药品上市后安全有效的保障。加强药物临床试验监督管理,对提高新药临床试验质量具有重大的意义。我国CCP规范强调了药物临床试验中质量管理的重要性,其中监查是保证药物临床试验质量的一个重要环节。但目前新药临床试验中的监查还存在一定的问题,需要通过分析问题产生的根源,探讨解决的办法,提出加强药物临床试验过程的监查,使药物临床试验质量得到进一步提高。
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| 关 键 词： | 临床试验 药物评价 全面质量管理 监查 |
| 文章编号： | 1007-7669(2008)04-0300-03 |
| 修稿时间： | 2008年1月15日 |
Improvement of pharmacentical clinical trial quality by enhancing inspection of procedure |
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| SONG Ping,TANG Xue-chun,ZHANG Xun.Improvement of pharmacentical clinical trial quality by enhancing inspection of procedure[J].Chinese Journal of New Drugs and Clinical Remedies,2008,27(4):300-302. |
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| Authors: | SONG Ping TANG Xue-chun ZHANG Xun |
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| Abstract: | The quality of clinical trials for new drugs can effectively guarantee the safety administration after available on market;thus enhancing the inspection of drug clinical trials is important to the quality control of new drug.The GCP regulation of our country stresses the importance of quality control for the procedure of new drug clinical trials,emphasizing that the inspection is one of the crucial steps.However,some problems are still yet to be solved,they might be passed through tracing the couses,strengthening the inspection for clinical trials and proving the final improvement in quality. |
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| Keywords: | clinical trials drug evaluation total quality management monitoring |
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