药物基因组学在药物试验、药品标签及药物处方基因检测方面的法律影响：一种国际方法。
Legal implications of pharmacogenomics regarding drug trials, drug labeling, and genetic testing for drug prescription: an international approach.
作者信息
Mandry Tilo
出版信息
Food Drug Law J. 2004;59(4):519-35.
Pharmacogenomics applies genomic technology to discover and develop drugs as well as to treat patients more effectively. This article addresses legal questions raised by pharmacogenomics, from drug development to drug use. Part II defines pharmacogenomics in further detail and explains the use of pharmacogenomics in drug development. Part III identifies potential legal questions raised by this approach to drug development and delivery. Parts IV to VIII offer possible solutions to these potential problems, analyzing the law in both the United States and the European Union (EU).
药物基因组学应用基因组技术来发现和开发药物，并更有效地治疗患者。本文探讨了药物基因组学引发的法律问题，从药物研发到药物使用。第二部分更详细地定义了药物基因组学，并解释了药物基因组学在药物研发中的应用。第三部分指出了这种药物研发和递送方法可能引发的潜在法律问题。第四部分至第八部分针对这些潜在问题提供了可能的解决方案，分析了美国和欧盟（EU）的法律。
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