title: Pharmacogenomic data submissions to the FDA: non-clinical case studies.
authors.affiliation: Division of Oncology Drug Products, CDER, FDA, 5600 Fishers Lane, Rockville, MD 20850, USA. leightonj@cder.fda.gov
authors.forename: John K
authors.initials: JK
authors.lastname: Leighton
authors.forename: Joseph
authors.initials: J
authors.lastname: DeGeorge
authors.forename: David
authors.initials: D
authors.lastname: Jacobson-Kram
authors.forename: James
authors.initials: J
authors.lastname: MacGregor
authors.forename: Donna
authors.initials: D
authors.lastname: Mendrick
authors.forename: Alexandra
authors.initials: A
authors.lastname: Worobec
mesh_terms: D016022:Case-Control Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence