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Modeling and predicting drug pharmacokinetics in patients with renal impairment

Rowland Yeo, K. and Aarabi, M. and Jamei, M. and Rostami-Hodjegan, A. (2011) Modeling and predicting drug pharmacokinetics in patients with renal impairment. Expert Review of Clinical Pharmacology, 4 (2). pp. 261-274. ISSN 17512433 (ISSN)

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Abstract

Current guidance issued by the US FDA to assess the impact of renal impairment on the pharmacokinetics of a drug under development has recently been updated to include evaluation of drugs with nonrenal elimination routes. Renal impairment not only affects elimination of the drug in the kidney, but also the nonrenal route of drugs that are extensively metabolized in the liver. Renal failure may influence hepatic drug metabolism either by inducing or suppressing hepatic enzymes, or by its effects on other variables such as protein binding, hepatic blood flow and accumulation of metabolites. Prior simulation of the potential exposure of individuals with renal impairment may help in the selection of a safe and effective dosage regimen. In this article, we discuss the application of a systems biology approach to simulate drug disposition in subjects with renal impairment. © 2011 Expert Reviews Ltd.

Item Type: Article
Additional Information: Unmapped bibliographic data: LA - English [Field not mapped to EPrints] J2 - Expert Rev. Clin. Pharmacol. [Field not mapped to EPrints] C2 - 22115405 [Field not mapped to EPrints] AD - Simcyp Limited, Blades Enterprise Centre, John Street, Sheffield, S2 4SU, United Kingdom [Field not mapped to EPrints] AD - School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran [Field not mapped to EPrints] AD - School of Pharmacy and Pharmaceutical Sciences, Faculty of Medical and Human Sciences, University of Manchester, Manchester, United Kingdom [Field not mapped to EPrints] DB - Scopus [Field not mapped to EPrints]
Uncontrolled Keywords: in vitro-in vivo extrapolation, metabolism, modeling, pharmacokinetics, renal impairment, systems biology, cytochrome P450, diltiazem, erythromycin, midazolam, paroxetine, quinidine, repaglinide, simvastatin, triazolam, angina pectoris, area under the curve, chronic kidney disease, drug absorption, drug bioavailability, drug blood level, drug clearance, drug disposition, drug distribution, enzyme activity, gastrointestinal absorption, generalized anxiety disorder, glomerulus filtration rate, heart arrhythmia, human, hypertension, kidney function, major depression, mathematical model, maximum plasma concentration, non insulin dependent diabetes mellitus, nonhuman, obsessive compulsive disorder, panic, prediction, review, single drug dose, social phobia, systems biology, urinary excretion, Animals, Clinical Trials, Phase III as Topic, Forecasting, Humans, Kidney Diseases, Metabolic Clearance Rate, Models, Biological, Models, Chemical, Pharmaceutical Preparations
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
موارد کلی
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 18 Apr 2015 04:15
Last Modified: 16 May 2015 15:10
URI: http://eprints.goums.ac.ir/id/eprint/2143

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