{"title":"Pharmacogenomics and pharmacologic class effect in drug safety management.","authors":"Mikyung Kim","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.3000,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and drug law journal","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
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.