Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine

DSpace/Manakin Repository

Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine

Citable link to this page

. . . . . .

Title: Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine
Author: Fahnestock, Derek
Citation: Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine (2005 Third Year Paper)
Full Text & Related Files:
Abstract: Pharmacogenomic 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.
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889482

Show full Dublin Core record

This item appears in the following Collection(s)

 
 

Search DASH


Advanced Search
 
 

Submitters