药物基因组学与药理学类效应在药物安全管理中的应用。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2014-01-01
Mikyung Kim
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引用次数: 0

摘要

fda批准的药物的安全性仍然是患者和医疗从业者关注的一个重要问题。本文认为,药物基因组学可以补充药物安全管理中的药理学类效应,并且可以在不增加成本或其他不切实际的情况下实施。本文第一部分介绍了关键数据、概念和术语;第二节讨论了药理学类效应现象,以及这一现象与药物基因组学在FDA监管和医疗实践中的应用之间的关系;第三部分提出了同时考虑药理学类效应和药物基因组学可以提高选择性风险管理质量的方法。
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Pharmacogenomics and pharmacologic class effect in drug safety management.

The safety of FDA-approved drugs remains a significant concern for patients and medical practitioners. This paper argues that pharmacogenomics can complement pharmacologic class effects in drug-safety management, and their use can be implemented without excessive costs or other impracticalities. Section I of this paper introduces key data, concepts and terms; Section II discusses the phenomenon of pharmacologic class effect as well as the relationship between this phenomenon and the use of pharmacogenomics in both FDA regulation and medical practice; and Section III proposes a means by which simultaneous consideration of pharmacologic class effect and pharmacogenomics can improve the quality of selective risk management.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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