| 美国与欧盟药物研制中的儿童用药研究计划初探 |
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| 引用本文： | 赵岩松,洪兰,叶桦. 美国与欧盟药物研制中的儿童用药研究计划初探[J]. 中国药事, 2017, 31(4): 358-363 |
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| 作者姓名： | 赵岩松 洪兰 叶桦 |
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| 作者单位： | 复旦大学药学院, 上海 201203;罗氏中国投资有限公司, 上海 201203,复旦大学药学院, 上海 201203,复旦大学药学院, 上海 201203 |
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| 摘 要： | 目的：详细介绍了美国、欧盟法规中的儿童用药研发计划，希望为我国的儿童用药法规提供参考和借鉴。方法：分析、对比美国和欧盟的儿童用药研发计划，同时对我国目前的儿童用药政策作了简要介绍。结果与结论：我国的儿童用药法规可以借鉴美国与欧盟的经验，逐步推进儿童用药研发计划的做法。
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| 关 键 词： | 儿童用药研究计划 药品研制 政策法规 |
| 收稿时间： | 2016-09-13 |
Exploration of Pediatric Study / Investigation Plan in Drug Research and Development in the US and the EU |
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| Zhao Yansong,Hong Lan and Ye Hua. Exploration of Pediatric Study / Investigation Plan in Drug Research and Development in the US and the EU[J]. Chinese Pharmaceutical Affairs, 2017, 31(4): 358-363 |
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| Authors: | Zhao Yansong Hong Lan Ye Hua |
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| Affiliation: | School of Pharmacy, Fudan University, Shanghai 201203, China;Roche China Holding Ltd., Shanghai 201203, China,School of Pharmacy, Fudan University, Shanghai 201203, China and School of Pharmacy, Fudan University, Shanghai 201203, China |
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| Abstract: | Objective: To present the FDA pediatric study plan and EMA pediatric investigation plans in detail, to provide references for pediatric regulations in China. Method: The pediatric study plans in the US and the EU were analyzed and compared. The pediatric regulations and guidelines in China were briefly introduced. Results and Conclusion: China may learn experiences from the US and the EU, so as to gradually promote the pediatric research plan. |
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| Keywords: | pediatric study plan drug research and development regulation and guideline |
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