Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power

Author(s): Trevor Johnson, Thomas Kerbusch, Barry Jones, Geoffrey Tucker, Amin Rostami-Hodjegan, Peter Milligan
Year: July 1, 2009

The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions

Author(s): Bill Poland, Lee Hodge, Anis Khan, Robert Clemen, John Wagner, Kevin Dykstra, Rajesh Krishna
Year: July 1, 2009

On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies

Author(s): Rene Bruno, Laurent Claret
Year: August 1, 2009

Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain

Author(s): Sunita Babbar, Jean-Francois Marier, Mohamad-Samer Mouksassi, Martin Beliveau, Geertrui Vanhove, Sanjay Chanda, Keith Bley
Year: August 1, 2009

Excluding Venous Thromboembolism Using Point of Care D-dimer Tests in Outpatients: A Diagnostic Meta-analysis

Author(s): Geert-Jan Geersing, Arno Hoes, Johannes Reitsma, Karel Moons, Kristel Janssen, Ruud Oudega, Leon Bax
Year: August 14, 2009

Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics

Author(s): Laurent Claret, Pascal Girard, Paulo Hoff, Eric Van Cutsem, Klaas Zuideveld, Karin Jorga, Jan Fagerberg, Rene Bruno
Year: September 1, 2009

Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs

Author(s): Shashank Rohatagi, Timothy Carrothers, Jonathan Wagg, Tatiana Khariton
Year: November 1, 2009

Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome

Author(s): Mohamad-Samer Mouksassi, Jean-Francois Marier, Jane Cyran, Alexander Vinks
Year: December 1, 2009

Population Pharmacokinetics of Teduglutide Following Repeated Subcutaneous Administrations in Healthy Participants and in Patients with Short Bowel Syndrome and Crohn’s Disease

Author(s): Jean-Francois Marier, Mohamad-Samer Mouksassi, Nathalie Gosselin, Martin Beliveau, Jane Cyran, John Wallens
Year: January 1, 2010

The Use of Biosimulation in the Design of a Novel Multilevel Weight Loss Maintenance Program for Overweight Children

Author(s): Denise Wilfley, Dorothy Van Buren, Kelly Theim, Richard Stein, Brian Saelens, Farkad Ezzet, Angela Russian, Michael Perri, Leonard Epstein
Year: February 18, 2010

Detection of Lymph Node Metastases by Gadolinium-enhanced Magnetic Resonance Imaging: Systematic Review and Meta-analysis

Author(s): Wenche Klerkx, Leon Bax, Wouter Veldhuis, A. Peter Heintz, Willem Mali, Petra Peeters, Karel Moons
Year: February 24, 2010

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

Author(s): Trevor Johnson, Koen Boussery, Karen Rowland Yeo, Geoffrey Tucker, Amin Rostami-Hodjegan
Year: March 1, 2010

Under-reporting of Venous and Arterial Thrombotic Events in Randomized Clinical Trials: A Meta-analysis

Author(s): Danka Stuijver, Erica Romualdi, Bregje van Zaane, Leon Bax, Harry Büller, Victor Gerdes, Alessandro Squizzato
Year: March 1, 2010

Physiologically-based Mechanistic Modeling 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

Author(s): Karen Rowland Yeo, Masoud Jamei, Jiansong Yang, Geoffrey Tucker, Amin Rostami-Hodjegan
Year: March 18, 2010

Population Pharmacokinetic/Pharmacodynamic Model for a C.E.R.A. in Both ESA-naive and ESA-treated Chronic Kidney Disease Patients with Renal Anemia

Author(s): Pascal Chanu, Ronald Gieschke, Jean‐Eric Charoin, Anne Pannier, Bruno Reigner
Year: May 1, 2010

Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis

Author(s): Brendan McGuire, Igor Zupanets, Mark Lowe, Xunjun Xiao, Vasyliy Syplyviy, Jonathan Monteleone, Sharron Gargosky, Klara Dickinson, Antonia Martinez, Masoud Mokhtarani, Bruce Scharschmidt
Year: June 1, 2010

Relationship Between Exposure to Sunitinib and Efficacy and Tolerability Endpoints in Patients with Cancer: Results of a Pharmacokinetic/Pharmacodynamic Meta-analysis

Author(s): Brett Houk, Carlo Bello, Bill Poland, Lee Rosen, George Demetri, Robert Motzer
Year: July 1, 2010

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

Author(s): Rene Bruno, Jian‐Feng Lu, Yi-Na Sun, L. Claret
Year: July 13, 2010

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

Author(s): Angèle Fleury, Thierry Lavé, Fredrik Jonsson, Monique Schmitt, Gerard Hirkaler, Liudmila Polonchuk, Alexander Breidenbach
Year: August 21, 2010

Randomised, Parallel-group, Multicenter, Multinational Phase 2 Study Comparing Edoxaban, an Oral Factor Xa Inhibitor, with Warfarin for Stroke Prevention in Patients with Atrial Fibrillation

Author(s): Jeffrey Weitz, Stuart Connolly, Isha Patel, Diego Salazar, Shashank Rohatagi, Mendel Jansen, Helen Kastrissios, Jingjing Jin, Satoshi Kunitada
Year: September 1, 2010