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Pubmed ID :29788596
Publication Date : //

Innovation in personalized medicine: BiDil as a case study for integrating clinical and policy developments.


BiDil (hydralazine and isosorbide dinitrate) represents an interesting application of personalized medicine - the first pharmaceutical specifically approved by a regulatory agency, the US FDA, for an indication in a particular population based on race as a surrogate phenotypic marker, without a companion genomic diagnostic directed at measuring drug responsiveness. The focus of this paper is to use BiDil as a case study of a personalized medicine application and evaluate its clinical and policy-relevant characteristics as an illustrative example of the usefulness of the Evaluation Data for Assessing Personalized Medicine Translation (EDAPT) evidence base.

Authors : Issa Amalia M , Todd Weiss L , Tufail Waqas , Phillips Kathryn A , Van Bebber Stephanie L ,

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