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

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

(2011) Malcolm Rowland et al.   Annual Review of Pharmacology and Toxicology

A Semi-Mechanistic Model to Predict the Effects of Liver Cirrhosis on Drug Clearance

(2010) Trevor N. Johnson et al.   CLINICAL PHARMACOKINETICS

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

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

Pharmacokinetic modeling of the hepatobiliary transport mediated by cooperation of uptake and efflux transporters

(2010) Hiroyuki Kusuhara et al.   DRUG METABOLISM REVIEWS

Application of physiologically based pharmacokinetic modeling and clearance concept to drugs showing transporter-mediated distribution and clearance in humans

(2010) Takao Watanabe et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

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

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

(2009) Masoud Jamei et al.   Drug Metabolism and Pharmacokinetics

Physiologically based mechanistic modelling to predict complex drug–drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut—The effect of diltiazem on the time-course of exposure to triazolam

(2009) Karen Rowland Yeo et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

The Simcyp®Population-based ADME Simulator

(2009) Masoud Jamei et al.   Expert Opinion on Drug Metabolism & Toxicology

Physiology-Based Simulations of a Pathological Condition

(2008) Andrea N Edginton et al.   CLINICAL PHARMACOKINETICS

Effects of Gemfibrozil and Atorvastatin on the Pharmacokinetics of Repaglinide in Relation to SLCO1B1 Polymorphism

(2008) A Kalliokoski et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

The effect of chronic renal failure on drug metabolism and transport

(2008) Albert W Dreisbach et al.   Expert Opinion on Drug Metabolism & Toxicology

Identification of the cytochrome P450 enzymes involved in the N-demethylation of sildenafil

(2003) R. Hyland et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY