Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

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

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

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

In Vitro and In Vivo P-Glycoprotein Transport Characteristics of Rivaroxaban

(2011) M. J. Gnoth et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Modeling and predicting drug pharmacokinetics in patients with renal impairment

(2011) Karen Rowland Yeo et al.   Expert Review of Clinical Pharmacology

Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor

(2010) Dagmar Kubitza et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

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

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

Confidence Assessment of the Simcyp Time-Based Approach and a Static Mathematical Model in Predicting Clinical Drug-Drug Interactions for Mechanism-Based CYP3A Inhibitors

(2010) Y.-H. Wang   DRUG METABOLISM AND DISPOSITION

Prediction of Human Drug-Drug Interactions from Time-Dependent Inactivation of CYP3A4 in Primary Hepatocytes Using a Population-Based Simulator

(2009) L. Xu et al.   DRUG METABOLISM AND DISPOSITION

Metabolism and Excretion of Rivaroxaban, an Oral, Direct Factor Xa Inhibitor, in Rats, Dogs, and Humans

(2009) C. Weinz et al.   DRUG METABOLISM AND DISPOSITION

In Vitro Metabolism of Rivaroxaban, an Oral, Direct Factor Xa Inhibitor, in Liver Microsomes and Hepatocytes of Rats, Dogs, and Humans

(2009) D. Lang et al.   DRUG METABOLISM AND DISPOSITION

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

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

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

Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects

(2008) Dagmar Kubitza et al.   CURRENT MEDICAL RESEARCH AND OPINION

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