Article
Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use.
Drug safety - 1 Jun 2020
Jerome Rebecca N, Joly Meghan Morrison, Kennedy Nan, Shirey-Rice Jana K, Roden Dan M, Bernard Gordon R, Holroyd Kenneth J, Denny Joshua C, Pulley Jill M
Abstract excerpt
INTRODUCTION: When a new drug or biologic product enters the market, its full spectrum of side effects is not yet fully understood, as use in the real world often uncovers nuances not suggested within the relatively narrow confines of preapproval preclinical and trial work. OBJECTIVE: We describe a new, phenome-wide association study (PheWAS)- and evidence-based approach for detection of potential adverse drug...
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