Regulatory Perspectives on Designing Pharmacokinetic Studies and Optimizing Labeling Recommendations for Patients With Chronic Kidney Disease

A New Equation to Estimate Glomerular Filtration Rate

(2013) Andrew S. Levey et al.   ANNALS OF INTERNAL MEDICINE

Evaluation of Exposure Change of Nonrenally Eliminated Drugs in Patients With Chronic Kidney Disease Using Physiologically Based Pharmacokinetic Modeling and Simulation

(2012) Ping Zhao et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Clinical Pharmacology Basis of Deriving Dosing Recommendations for Dabigatran in Patients With Severe Renal Impairment

(2011) Sudharshan Hariharan et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Estimating the Glomerular Filtration Rate in Obese Adult Patients for Drug Dosing

(2010) Manjunath P. Pai   ADVANCES IN CHRONIC KIDNEY DISEASE

Hepatic Clearance, but Not Gut Availability, of Erythromycin Is Altered in Patients With End-Stage Renal Disease

(2010) H Sun et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Role of Clinical Pharmacology in Supporting the Emergency Use Authorization of an Unapproved Anti-Influenza Drug, Peramivir

(2010) V Arya et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Evaluation of Renal Drug Dosing: Prescribing Information and Clinical Pharmacist Approaches

(2010) Thomas C Dowling et al.   PHARMACOTHERAPY

Modified diet in renal disease method overestimates renal function in selected elderly patients

(2009) G. W. Roberts et al.   AGE AND AGEING

Comparison of Drug Dosing Recommendations Based on Measured GFR and Kidney Function Estimating Equations

(2009) Lesley A. Stevens et al.   AMERICAN JOURNAL OF KIDNEY DISEASES

When to Conduct a Renal Impairment Study During Drug Development: US Food and Drug Administration Perspective

(2009) S-M Huang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Drug Development Perspective on Pharmacokinetic Studies of New Drugs in Patients With Renal Impairment

(2009) R L Lalonde et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Pharmacokinetic Studies in Hemodialysis Patients

(2009) A J Atkinson et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Nephropharmacology: Drugs and the Kidney

(2009) A J Atkinson et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Use of the MDRD Study Equation to Estimate Kidney Function for Drug Dosing

(2009) L A Stevens et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Continuing the Use of the Cockcroft–Gault Equation for Drug Dosing in Patients With Impaired Renal Function

(2009) W J Spruill et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Reporting Estimated GFR: A Laboratory Perspective

(2008) W. Greg Miller   AMERICAN JOURNAL OF KIDNEY DISEASES

Emerging Evidence of the Impact of Kidney Disease on Drug Metabolism and Transport

(2008) TD Nolin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications

(2008) Y Zhang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Altered nonrenal drug clearance in ESRD

(2008) Thomas D Nolin   CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION

Effect of Hemodialysis on Hepatic Cytochrome P450 Functional Expression

(2008) Josée Michaud et al.   JOURNAL OF PHARMACOLOGICAL SCIENCES

Cockcroft-Gault Versus Modification of Diet in Renal Disease

(2008) Chiara Melloni et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Quelle méthode d’évaluation de la fonction rénale utiliser chez le sujet âgé hospitalisé en unité de court séjour gériatrique ? Comparaison de quatre méthodes

(2008) C. Carbonnel et al.   REVUE DE MEDECINE INTERNE