• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Science, Technology and Human Values >Deficits, Expectations and Paradigms in British and American Drug Safety Assessments
【24h】

Deficits, Expectations and Paradigms in British and American Drug Safety Assessments

机译：英美药物安全评估的不足，期望和范例

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

This article examines the regulation of nonsteroidal anti-inflammatory drugs (NSAIDs), with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both that these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science (including deficits), on the other.
机译：本文研究了非甾体类抗炎药（NSAIDs）的法规，特别侧重于在英国获准销售的产品，但出于安全原因在美国被拒绝了市场销售的批准，然后基于这些理由从英国市场撤出理由。通过对政府和公司外部从未有过的监管数据进行国际比较，以及与相关行业科学家和监管机构的访谈，本文证明了监管期望，缺陷和范式的重要性。有人认为，这些社会学概念可以通过将其应用到详细的监管科学比较案例研究中而得到充实，并且它们提供了一个重要的与政策相关的框架，可以用来理解社会历史背景下的不同药物监管过程。发现，监管期望和范式一方面可以被视为政治文化与结构性利益之间的中介因素，另一方面可以被视为监管科学的结果（包括赤字）之间的中介因素。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号