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

Author:

Issa Amalia M1,Todd Weiss L1,Tufail Waqas1,Phillips Kathryn A2,Van Bebber Stephanie L2

Affiliation:

1. The Methodist Hospital and University of Houston, Program in Personalized Medicine & Targeted Therapeutics and the Abramson Center for the Future of Health, 300 Technology Building, T2–309, Houston, TX 77204–4021, USA.

2. University of California, Department of Clinical Pharmacy, School of Pharmacy, San Francisco, 521 Parnassus Avenue, C-152 Box 0622, University of California, San Francisco, CA 94143–0622, USA

Abstract

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.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Molecular Medicine,General Medicine

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