title: Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans.
authors.affiliation: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD 20857, USA.
authors.forename: J
authors.initials: J
authors.lastname: Choudary
authors.forename: J F
authors.initials: JF
authors.lastname: Contrera
authors.forename: A
authors.initials: A
authors.lastname: DeFelice
authors.forename: J J
authors.initials: JJ
authors.lastname: DeGeorge
authors.forename: J G
authors.initials: JG
authors.lastname: Farrelly
authors.forename: G
authors.initials: G
authors.lastname: Fitzgerald
authors.forename: M A
authors.initials: MA
authors.lastname: Goheer
authors.forename: A
authors.initials: A
authors.lastname: Jacobs
authors.forename: A
authors.initials: A
authors.lastname: Jordan
authors.forename: L
authors.initials: L
authors.lastname: Meyers
authors.forename: R
authors.initials: R
authors.lastname: Osterberg
authors.forename: C
authors.initials: C
authors.lastname: Resnick
authors.forename: C J
authors.initials: CJ
authors.lastname: Sun
authors.forename: R J
authors.initials: RJ
authors.lastname: Temple
mesh_terms: D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010600:Pharmacology; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations