title: Legal implications of pharmacogenomics regarding drug trials, drug labeling, and genetic testing for drug prescription: an international approach.
abstract: 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).
authors.forename: Tilo
authors.initials: T
authors.lastname: Mandry
mesh_terms: D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D004247:DNA / Q000737:chemistry; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D015195:Drug Design; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004992:Ethics, Medical; D005062:European Union; D005820:Genetic Testing; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D017387:Investigational New Drug Application; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations; D010597:Pharmacogenetics / Q000191:economics / Q000331:legislation & jurisprudence*; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations; D004247:DNA