Physiologically-Based Pharmacokinetic Modeling of Macitentan: Prediction of Drug–Drug Interactions

Investigation of mutual pharmacokinetic interactions between macitentan, a novel endothelin receptor antagonist, and sildenafil in healthy subjects

(2014) Patricia N. Sidharta et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Investigation of the Effect of Macitentan on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects

(2014) Patricia N. Sidharta et al.   CLINICAL DRUG INVESTIGATION

Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration

(2014) Christian Wagner et al.   CLINICAL PHARMACOKINETICS

Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

(2014) V Sinha et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

(2013) Nikolaos Tsamandouras et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Investigation of the Effects of Ketoconazole on the Pharmacokinetics of Macitentan, a Novel Dual Endothelin Receptor Antagonist, in Healthy Subjects

(2013) Jacob Atsmon et al.   CLINICAL PHARMACOKINETICS

Updated Treatment Algorithm of Pulmonary Arterial Hypertension

(2013) Nazzareno Galiè et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Pharmacokinetics of Macitentan in Caucasian and Japanese Subjects: The Influence of Ethnicity and Sex

(2013) Shirin Bruderer et al.   PHARMACOLOGY

The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review

(2012) S-M Huang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Slow Receptor Dissociation Kinetics Differentiate Macitentan from Other Endothelin Receptor Antagonists in Pulmonary Arterial Smooth Muscle Cells

(2012) John Gatfield et al.   PLoS One

Absorption, distribution, metabolism, and excretion of macitentan, a dual endothelin receptor antagonist, in humans

(2012) Shirin Bruderer et al.   XENOBIOTICA

Effect of Cyclosporine and Rifampin on the Pharmacokinetics of Macitentan, a Tissue-Targeting Dual Endothelin Receptor Antagonist

(2011) Shirin Bruderer et al.   AAPS Journal

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

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

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

(2011) A. S. Darwich et al.   CURRENT DRUG METABOLISM

HIV infection and pulmonary arterial hypertension

(2011) Stefania Cicalini et al.   Expert Review of Respiratory Medicine

Modelling and PBPK Simulation in Drug Discovery

(2009) Hannah M. Jones et al.   AAPS Journal

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

Comparison of the dissolution and pharmacokinetic profiles of two galenical formulations of the endothelin receptor antagonist macitentan

(2009) Oliver Kummer et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Quantitative Evaluation of Pharmacokinetic Inhibition of CYP3A Substrates by Ketoconazole: A Simulation Study

(2009) Ping Zhao et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Whole body physiologically-based pharmacokinetic models: their use in clinical drug development

(2008) Andrea N Edginton et al.   Expert Opinion on Drug Metabolism & Toxicology

Pharmacology of Macitentan, an Orally Active Tissue-Targeting Dual Endothelin Receptor Antagonist

(2008) M. Iglarz et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS