| 美国孤儿药开发的政策、策略与实践 |
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| 引用本文： | 杜涛.美国孤儿药开发的政策、策略与实践[J].微生物学杂志,2015(8). |
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| 作者姓名： | 杜涛 |
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| 作者单位： | 1. 美国汉佛莱医药顾问有限公司，马里兰 柏赛斯塔 20817；2. 思路迪医药科技有限公司，北京 100176 |
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| 摘 要： | 简述了罕见病及孤儿药的定义和研发意义，重点介绍了美国针对孤儿药开发的现有制度法规、激励政策及管理经验，并以实例
分析从研发、注册和上市等角度探讨了美国孤儿药开发的策略，旨在为从事孤儿药开发工作的人士提供参考。
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| 关 键 词： | 孤儿药 罕见病 激励政策 开发策略 |
Policies, Strategies and Practices of Orphan Drug Development in the United States |
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| DU Tao.Policies, Strategies and Practices of Orphan Drug Development in the United States[J].Journal of Microbiology,2015(8). |
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| Authors: | DU Tao |
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| Institution: | 1.Humphries Pharmaceutical Consulting, LLC, Bethesda 20817, USA; 2. 3D Medicines Inc., Beijing 100176, China |
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| Abstract: | This article briefly introduced the definitions and research significance of rare diseases and orphan drugs. Current US regulations,
incentive policies and management experience on orphan drugs were reviewed. Case analyses were provided to discuss strategies in orphan drug
development in US from the aspects of R&D, registration and commercialization, so as to provide references for orphan drug researchers. |
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| Keywords: | orphan drug rare disease incentive policy R&D strategy |
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