Prediction of the Effect of Renal Impairment on the Pharmacokinetics of New Drugs

• Published in: Clinical pharmacokinetics Vol. 57; no. 4; pp. 505 - 514
• Main Authors: Borella, Elisa, Poggesi, Italo, Magni, Paolo
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.04.2018; Springer Nature B.V
• Subjects: Cancer; Computer Simulation; Cytochrome; Data Mining; Databases, Factual; Drug dosages; Drugs, Investigational - administration & dosage; Drugs, Investigational - pharmacokinetics; Enzymes; Glomerular Filtration Rate; Glycoproteins; Humans; Internal Medicine; Kidney - physiopathology; Kidney diseases; Kidney Diseases - diagnosis; Kidney Diseases - physiopathology; Medicine; Medicine & Public Health; Metabolism; Metabolites; Models, Biological; Multivariate analysis; Original Research Article; Pharmacokinetics; Pharmacology/Toxicology; Pharmacotherapy; Plasma; Proteins; Renal Elimination; United States > US

Introduction Renal impairment may have a significant impact on the pharmacokinetics of drugs. Ad hoc studies in subjects with renal impairment are required by the regulatory authorities to propose dose adjustments in these subjects, to find a dosing regimen able to provide a systemic exposure simila...