title: Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.
abstract: The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition.
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington.
authors.forename: Jingjing
authors.initials: J
authors.lastname: Yu
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington.
authors.forename: Tasha K
authors.initials: TK
authors.lastname: Ritchie
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington.
authors.forename: Aditi
authors.initials: A
authors.lastname: Mulgaonkar
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington imaj@uw.edu.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Ragueneau-Majlessi
mesh_terms: D004347:Drug Interactions / Q000502:physiology*; D006801:Humans; D008658:Inactivation, Metabolic / Q000502:physiology*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations