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dc.contributor.advisorHutt, Peter Bartonen_US
dc.contributor.authorFahnestock, Dereken_US
dc.date.accessioned2012-06-15T20:53:04Z
dc.date.issued2005en_US
dc.identifier.citationAccomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine (2005 Third Year Paper)en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8889482
dc.description.abstractPharmacogenomic technologies promise to usher in an era of individualized medicine, but also pose challenges to a regulatory regime without experience dealing with the sorts of data produced by these techniques. Pharmacogenomics as a field encompasses both pharmacogenetic techniques, which tend to focus on polymorphisms in cytochromes and other proteins involved in drug metabolism, and pharmacogenomic techniques such as microarray technologies, which examine disease and drug interactions on the level of the entire genome. In 2003, the FDA produced a guidance recommending procedures for the submission of pharmacogenomic data at the IND or NDA stage. While pharmacogenomic information used in decision making; during trials is required, most pharmacogenomic data of an exploratory nature may be submitted voluntarily under a separate protocol. Though these procedures seem a reasonable means by which the FDA can open a dialogue with pharmaceutical manufacturers regarding the use of pharmacogenomic data, more action is necessary to develop the infrastructure necessary to develop the technology such that in may be incorporated in regulatory decisions with confidence.en
dc.language.isoen_USen
dash.licenseLAAen_US
dc.subjectFood and Drug Lawen
dc.subjectpharmacogenomicsen
dc.titleAccomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicineen
dc.typePaper (for course/seminar/workshop)en_US
dc.date.available2012-06-15T20:53:04Z
dash.authorsorderedfalse


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