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

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http://hdl.handle.net/10138/302836

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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

Titel: Clinical Studies on Drug-Drug Interactions Involving Metabolism and Transport : Methodology, Pitfalls, and Interpretation
Författare: Tornio, Aleksi; Filppula, Anne M.; Niemi, Mikko; Backman, Janne T.
Upphovmannens organisation: Department of Clinical Pharmacology
INDIVIDRUG - Individualized Drug Therapy
Research Programs Unit
Medicum
Clinicum
Mikko Olavi Niemi / Principal Investigator
Janne Backman / Principal Investigator
HUSLAB
Datum: 2019-06
Språk: eng
Sidantal: 17
Tillhör serie: Clinical Pharmacology and Therapeutics
ISSN: 0009-9236
DOI: https://doi.org/10.1002/cpt.1435
Permanenta länken (URI): http://hdl.handle.net/10138/302836
Abstrakt: 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.
Subject: TIME-DEPENDENT PHARMACOKINETICS
PLASMA-CONCENTRATIONS
ROSUVASTATIN PHARMACOKINETICS
INTERACTION ASSESSMENTS
ENDOGENOUS BIOMARKERS
MARKEDLY DECREASES
GRAPEFRUIT JUICE
GENEVA COCKTAIL
CYTOCHROME-P450
INHIBITION
317 Pharmacy
3111 Biomedicine
Referentgranskad: Ja
Licens: cc_by_nc_nd
Användningsbegränsning: openAccess
Parallelpublicerad version: acceptedVersion


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