title: Organ Impairment-Drug-Drug Interaction Database: A Tool for Evaluating the Impact of Renal or Hepatic Impairment and Pharmacologic Inhibition on the Systemic Exposure of Drugs.
abstract: The organ impairment and drug-drug interaction (OI-DDI) database is the first rigorously assembled database of pharmacokinetic drug exposure data from publicly available renal and hepatic impairment studies presented together with the maximum change in drug exposure from drug interaction inhibition studies. The database was used to conduct a systematic comparison of the effect of renal/hepatic impairment and pharmacologic inhibition on drug exposure. Additional applications are feasible with the public availability of this database.
authors.affiliation: Department of Pharmacy, School of Pharmacy, University of Washington Seattle, Washington, USA ; Drug Interaction Database Program, University of Washington Seattle, Washington, USA.
authors.forename: C K
authors.initials: CK
authors.lastname: Yeung
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: K
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, University of Tokyo Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kusama
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: H
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Drug Interaction Database Program, University of Washington Seattle, Washington, USA.
authors.forename: I
authors.initials: I
authors.lastname: Ragueneau-Majlessi
authors.affiliation: Drug Interaction Database Program, University of Washington Seattle, Washington, USA.
authors.forename: S
authors.initials: S
authors.lastname: Argon
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: L
authors.initials: L
authors.lastname: Li
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: P
authors.initials: P
authors.lastname: Chang
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: C D
authors.initials: CD
authors.lastname: Le
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: P
authors.initials: P
authors.lastname: Zhao
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, University of Tokyo Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Sugiyama
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring, Maryland, USA.
authors.forename: S-M
authors.initials: SM
authors.lastname: Huang