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美国儿童用药数据保护制度安全监控效应研究 被引量：1

Research on the Safety Monitoring Effects of Pediatric Drug Data Protection Regime in the US
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摘要 目的剖析美国儿童用药数据保护制度的安全监控效应并对提高我国儿童用药安全提供建议。方法在制度理论分析基础上,以芬太尼透皮贴剂Duragesic为案例开展实证研究。结果美国儿童用药数据保护制度有效提高药品安全监控效应。结论建议我国借鉴美国制度设立儿童用药数据保护机制,强化全生命周期风险管理及企业主体责任意识,提高儿童用药安全性。 OBJECTIVE To analyze the safety monitoring effects of pediatric drug data protection regime in the US and provide the suggestions to improve the safety of pediatric drugs in China. METHODS Theoretical analysis and case study of Duragesic（ Fentanyl transdermal patch）. RESULTS The pediatric drug data protection regime promoted safety monitoring effectively. CONCLUSION It is necessary to establish pediatric drug data protection system in China by referring to the experience of US,to enhance the lifecycle risk management and the responsibilities of enterprises,so as to improve the safety of pediatric drug.
作者 丁锦希 徐卓环 李苏菊 白庚亮
机构地区 中国药科大学医药知识产权研究所
出处 《中国药学杂志》 CAS CSCD 北大核心 2015年第12期1075-1078,共4页 Chinese Pharmaceutical Journal
基金 国家社会科学基金资助项目(13BFX120)
关键词 儿童用药 数据保护 安全监控效应 pediatric drug data protection safety monitoring
分类号 R951 [医药卫生—药学]
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参考文献12

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二级参考文献16

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中国药学杂志
2015年 第12期

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