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NBER色图书数据集:一个用户指南

Maya Durvasula1, C Scott Hemphill2, Lisa Larrimore Ouellette3

  • 1Department of Economics, Stanford University, United States of America.

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概括

美国食品和药物管理局的色书的新开放版将批准的药物与专利和监管排他性联系起来. 该资源为药物研究提供了有价值的数据,尽管研究人员必须谨慎地使用它.

关键词:
药品专利 药品专利 药品专利美国食品药品监督管理局 FDA FDA知识产权知识产权知识产权知识产权"色书"就是色的书.

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科学领域:

  • 制药科学 制药科学
  • 监管科学 监管科学
  • 数据科学数据科学数据科学

背景情况:

  • 美国食品和药物管理局 (FDA) 的色书是关键资源,将批准的药物与其专利和独家信息联系起来.
  • 从历史上看,对这些数据的访问是有限的,这阻碍了对药物生命周期和市场排他性的全面研究.

研究的目的:

  • 介绍FDA的色书的新数字化,开放式访问版本.
  • 讨论使用这种增强数据集用于研究目的的实用性,机遇和挑战.
  • 为了证明计算药物法律独家期限的用例.

主要方法:

  • 美国食品和药物管理局的色书数据的数字化.
  • 描述数据的覆盖范围,包括药物批准,专利和监管独家权.
  • 对数据的完整性和准确性与行政数据集的实证验证.

主要成果:

  • 现在可以获得"色书"的全面,开放式数字版本.
  • 数据验证表明,药物专利独家关系的记录基本上是完整和准确的.
  • 该资源有助于研究,例如计算药物法律独家期限.

结论:

  • 数字化书为制药和监管科学研究人员提供了有价值的,可访问的资源.
  • 了解和处理数据利用所需的选择是有效研究的关键.
  • 这些开放访问的数据有可能大大推进关于药物排他性和市场动态的研究.