新政府药物改用计划:机遇和不确定性
Johnathon Liddicoat1, Ashleigh Hamidzadeh1, Kathleen Liddell2
1Dickson Poon School of Law, King's College London, WC2R 2LS London, UK.
Science translational medicine
|June 26, 2024
概括
药物重新定位为新药开发提供了更快,更便宜的替代方案,但面临着监管障碍. 美国和欧洲的政策制定者已经启动了七个计划,以应对这些挑战,并推动药物重用倡议.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
- 监管科学 监管科学
背景情况:
- 与新药发现相比,药物重新定位是将治疗药物推向市场的成本效益高且加快的途径.
- 尽管有优势,但药物再利用的全部潜力仍然未得到充分利用,因为存在重大监管和知识产权障碍.
研究的目的:
- 检查美国和欧洲药物开发计划所采用的策略,旨在克服药物重用方面的挑战.
- 提供旨在促进重新用途药物的使用的政策倡议的概述.
主要方法:
- 分析了7个在美国和欧洲建立的药物开发计划.
- 审查政策文件和方案结构,解决药物重用中的监管和知识产权问题.
主要成果:
- 确定了在七个不同的药物开发计划中实施的一系列策略.
- 突出了政策制定者采取的各种方法来缓解与药物重新用途相关的挑战.
结论:
- 政策干预对于释放药物重新利用的好处至关重要.
- 研究的举措提供了有价值的模型,以促进其他地区的药物重新利用.
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