Clinical Studies on Drug-Drug Interactions Involving Metabolism and Transport : Methodology, Pitfalls, and Interpretation

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dc.contributor.author Tornio, Aleksi
dc.contributor.author Filppula, Anne M.
dc.contributor.author Niemi, Mikko
dc.contributor.author Backman, Janne T.
dc.date.accessioned 2019-06-13T10:20:03Z
dc.date.available 2019-06-13T10:20:03Z
dc.date.issued 2019-06
dc.identifier.citation Tornio , A , Filppula , A M , Niemi , M & Backman , J T 2019 , ' Clinical Studies on Drug-Drug Interactions Involving Metabolism and Transport : Methodology, Pitfalls, and Interpretation ' , Clinical Pharmacology and Therapeutics , vol. 105 , no. 6 , pp. 1345-1361 . https://doi.org/10.1002/cpt.1435
dc.identifier.other PURE: 125129077
dc.identifier.other PURE UUID: d752c5c8-32de-4ed1-b490-271266873ce3
dc.identifier.other WOS: 000467751900018
dc.identifier.other ORCID: /0000-0002-9577-2788/work/58509608
dc.identifier.other ORCID: /0000-0001-5713-5692/work/58510536
dc.identifier.uri http://hdl.handle.net/10138/302836
dc.description.abstract Many drug-drug interactions (DDIs) are based on alterations of the plasma concentrations of a victim drug due to another drug causing inhibition and/or induction of the metabolism or transporter-mediated disposition of the victim drug. In the worst case, such interactions cause more than tenfold increases or decreases in victim drug exposure, with potentially life-threatening consequences. There has been tremendous progress in the predictability and modeling of DDIs. Accordingly, the combination of modeling approaches and clinical studies is the current mainstay in evaluation of the pharmacokinetic DDI risks of drugs. In this paper, we focus on the methodology of clinical studies on DDIs involving drug metabolism or transport. We specifically present considerations related to general DDI study designs, recommended enzyme and transporter index substrates and inhibitors, pharmacogenetic perspectives, index drug cocktails, endogenous substrates, limited sampling strategies, physiologically-based pharmacokinetic modeling, complex DDIs, methodological pitfalls, and interpretation of DDI information. en
dc.format.extent 17
dc.language.iso eng
dc.relation.ispartof Clinical Pharmacology and Therapeutics
dc.rights cc_by_nc_nd
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject TIME-DEPENDENT PHARMACOKINETICS
dc.subject PLASMA-CONCENTRATIONS
dc.subject ROSUVASTATIN PHARMACOKINETICS
dc.subject INTERACTION ASSESSMENTS
dc.subject ENDOGENOUS BIOMARKERS
dc.subject MARKEDLY DECREASES
dc.subject GRAPEFRUIT JUICE
dc.subject GENEVA COCKTAIL
dc.subject CYTOCHROME-P450
dc.subject INHIBITION
dc.subject 317 Pharmacy
dc.subject 3111 Biomedicine
dc.title Clinical Studies on Drug-Drug Interactions Involving Metabolism and Transport : Methodology, Pitfalls, and Interpretation en
dc.type Article
dc.contributor.organization Department of Clinical Pharmacology
dc.contributor.organization INDIVIDRUG - Individualized Drug Therapy
dc.contributor.organization Research Programs Unit
dc.contributor.organization Medicum
dc.contributor.organization Clinicum
dc.contributor.organization Mikko Olavi Niemi / Principal Investigator
dc.contributor.organization Janne Backman / Principal Investigator
dc.contributor.organization HUSLAB
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1002/cpt.1435
dc.relation.issn 0009-9236
dc.rights.accesslevel openAccess
dc.type.version acceptedVersion
dc.type.version publishedVersion
dc.identifier.url https://rdcu.be/bGAZ8

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