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我国药物临床试验监督和管理的方法探讨
我国药物临床试验监督和管理的方法探讨
高建超,黄云虹,杨 焕,高晨燕

国家食品药品监督管理总局药品审评中心,北京 100038
Discussion on the supervision and management methods  of drug clinical trials in China
(Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China)

摘要参考文献相关文章

起始页:2149

摘要:[摘要] 随着我国药物临床试验的不断增加,对于药物临床试验的规范性和数据质量的要求越来越高。加强药物临床试验的监督和管理对于促进创新药的研发,保障人民用药安全有效有重要意义。我们通过对沟通交流、资料提交、质量管理和风险控制等方面进行探讨,为完善我国药物临床试验的监督管理体系提供建议。

关键词:[关键词] 药物临床试验;监督管理;方法探讨

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Abstract:[Abstract] With the continuous increase of clinical trials in China, the clinical norms and data quality requirements are getting higher. Strengthening the supervision and management of clinical trials is of great significance to promote the development of innovative drugs and ensure the medication safety and effectiveness in our people. Through discussing the communication, data submission, clinical trial quality management and risk control, we provide suggestions for improving the supervision and management system of drug clinical trials in China.

Key words:[Key words] drug clinical trial; supervision and management; method discussion

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