17th PAGE Meeting

  • Marseille - France
  • 18-20 June, 2008
Wednesday June 18
08:00-09:00 Registration
09:00-09:15 Welcome and Introduction
09:15-10:15 Oncology Session (invited speakers)

chair: René Bruno

09:15-09:45 Joga Gobburu The strategic use of modeling and simulation in oncology
09:45-10:15 Alwin Huitema Application of modelling and simulation in clinical oncology
10:15-10:20 Charlotte Kloft: Launch of the Graduate Research Training (GRT) Program 'Pharmacometrics & Computational Disease Modelling' in Germany
10:20-11:50 Coffee break, Poster and Software session I
Posters in Group I are accompanied by their presenter
11:50-12:30 Oral session continued (submitted abstracts) chair: Dinesh de Alwis
11:50-12:10 Laurent Claret A modeling framework to simulate Xeloda dose intensity and survival in colorectal cancer
12:10-12:30 Ines Paule Model-based dose adaptation of capecitabine for prevention of severe hand-and-foot syndrome: in silico comparison with the standard method
12:30-14:00 Lunch
14:00-15:00 Mats Karlsson and Nick Holford: A Tutorial on Visual Predictive Checkswith a link to the pdf of the presentation
15:00-16:30 Tea break, Poster and Software session II
Posters in Group II are accompanied by their presenter
16:30-17:30 Methodology/Applications chair: Oscar Della Pasqua
16:30-16:50 Eric Snoeck The challenge of modelling hepatitis C virus dynamics after long term treatment: Application of MONOLIX
16:50-17:10 Søren Klim Deconvolution of Insulin Secretion Rates
17:10-17:30 Lena Friberg Modeling and Simulation of the Asenapine Exposure-Response and Drop-Out in Acute Schizophrenia
Thursday June 19
09:00-10:20 Lewis Sheiner Student Session

chair: Silvy Laporte, Janet Wade and Stephen Duffull

09:00-09:25 Martin Bergstrand Modeling of gastro-intestinal tablet transit and its' effect on drug release and absorption for felodipine extended release tablet under fed or fasting conditions
09:25-09:50 Jakob Ribbing Modelling the Dynamics of Glucose, Insulin, Insulin Sensitivity and Beta-Cells in Subjects with Insulin Resistance and Patients with Type 2 Diabetes
09:50-10:15 Thuy Vu Time Course of Disease Status as a Predictor of Clinical Outcome in Parkinson's Disease
10:15-10:20 Presentation of Awards
10:20-11:50 Coffee break, Poster and Software session III
Posters in Group III are accompanied by their presenter
11:50-12:30 Applications chair: Charlotte Kloft
11:50-12:10 Michael Barras Individualized compared with conventional dosing of enoxaparin.
12:10-12:30 Marilee Andrew Effect of Cranberry Juice on Population Pharmacokinetics of Amoxicillin and Cefaclor
12:30-14:00 Lunch
14:00-15:00 Meindert Danhof and Bart Ploeger: Tutorial on Implementing Receptor Theory in PK-PD Modeling
15:00-16:30 Tea break, Poster and Software session IV
Posters in Group IV are accompanied by their presenter
16:30-17:30 Stuart Beal Methodology Session chair: France Mentré
16:30-16:50 Andrew Hooker Parameter estimation in non-linear mixed effects models using interval analysis
16:50-17:10 Christian Laveille Evaluation of the PK and PK-PD libraries of MONOLIX: A comparison with NONMEM
17:10-17:30 Elodie Plan Maximum Likelihood Estimation Methods: Performances in Count Response Models Population Parameters
19:00-24:00 Social evening
Friday June 20
09:00-10:00 Methodology: Design chair: Stephen Duffull
09:00-09:20 Joakim Nyberg Application of the optimal design approach to improve therapeutic drug monitoring for cyclosporine
09:20-09:40 Sylvie Retout Design optimisation in nonlinear mixed effects models using cost functions: application to a joint model of infliximab and methotrexate pharmacokinetics
09:40-10:00 Sergei Leonov Stochastic pharmacokinetic models: selection of sampling times
10:00-10:30 Coffee Break
10:30-11:30 Stuck in Modelling chair: Mats Karlsson, Iñaki Trocóniz, Stephen Duffull
10:30-11:00 Anthe Zandvliet PK-PD model of multiple follicular development with corifollitropin alfa during controlled ovarian stimulation: application of Markovian elements.
11:00-11:30 Nick Holford Attempts to describe disease progress and the action of oral hypoglycaemic agents in type 2 diabetes
11:30-11:40 Preview of PAGE 2009
11:40-12:20 Applications chair: Nick Holford
11:40-12:00 Joe Standing Predicting Paediatric Tobramycin Pharmacokinetics with Five Different Methods
12:00-12:20 Stephen Duffull A system model for the clotting cascade challenges clinical management of snake bites
12:20-12:30 Closing Remarks
12:30-12:45 Audience Input for the PAGE 2009 Program

All oral abstracts can be downloaded as a single document (rtf or pdf) and allposter abstracts can be downloaded as a single document (rtf or pdf).

Software demonstrations: Commercial

Pharsight: Phoenix platform, WinNonlin, Trial Simulator, WinNonlin AutoPilot, and PKS (a PK/PD data repository)
ICON Development Solutions: Hands-On Demonstration of PDx-Pop® v3.0; Tools for Expediting Population Analysis
Simcyp:Simcyp Simulator - a comprehensive platform and database for mechanistic modelling and simulation of oral drug absorption, tissue distribution, metabolism and elimination in healthy and disease populations using in vitro knowledge
GastroPlus: GastroPlus
Mango Solutions:Mango Solutions
PK-Sim:Hands-On Demonstrations of the Physiology-Based Pharmacokinetic Software, PK-Sim®

Software demonstrations: Non-commercial

Carlos Hoyo-Vadillo Four Programs for Writing and Running Nonmem Scripts
Roger Jelliffe The USC*PACK software for nonparametric adaptive grid (NPAG) population PK/PD modeling, and the MM-USCPACK clinical software for individualized drug regimens
Saik Urien RfN, R for Nonmem: A graphical interface for Nonmem outputs
Rich Haney Open Statistical Services
Andrew HookerPopED
Andrew Hooker Xpose and Perl speaks NONMEM(PsN)
Marc Lavielle Analysing population PK/PD data with MONOLIX 2.4 and writing complex models with MLXTRAN

Posters Wednesday Morning (group I)

Applications- Other topics

Corina Becker Whole-Body Physiologically-based Pharmacokinetic (WB-PBPK) Population Modelling to Simulate the Influence of Weight and Age on the Pharmacokinetics (PK) of a combined Oral Contraceptive Containing Drospirenone (DRSP) and Ethinylestradiol (EE)
Misba Beerahee Clinical Trial Simulation to Estimate the Sample Size for Investigation of the Impact of a Drug A on the Pharmacokinetics of Methotrexate, a common co-medication used in Rheumatoid Arthritis (RA)
Pascal Chanu Decisive support of Modeling & Simulation for getting drug approval in the context of safety concern on the drug class
Chao Chen Population PK/PD modelling of functional receptor occupancy in a first-time-in human study
Emmanuelle Comets Modelling is seldom used to describe pharmacokinetics in phase I clinical trials
Mike Dunlavey Simplified programming of population model user interfaces
Yumi Emoto Evaluation of Population PK/PD for Osteoporosis during a Vitamin D3 (1,25(OH)2D3) Derivative Therapy
Samuel Fanta Population Pharmacokinetics of Cyclosporine in Paediatric Renal Transplant Recipients
Dymphy Huntjens Receptor-mediated pharmacokinetic modeling of a novel anti-epileptic drug in healthy volunteers
Daniel Jonker The pharmacokinetics of the once-daily human glucagon-like peptide-1 analogue, liraglutide, across 5 trials in healthy subjects and type 2 diabetics after single and multiple dosing
Catherijne Knibbe Predictive Value of Allometric Scaling for Estimation of Propofol Clearance in Neonates, Infants and Adolescents
Elke Krekels Development AND External validation of a model for Glucuronidation in children below 3 years of age using morphine as a model drug; towards a novel dosing paradigm.
Glynn Morrish Using Body Composition Metrics to Predict Exposure Between Japanese and Caucasian Populations
Flora Musuamba-Tshinanu Limited sampling formulas and bayesian estimation for mycophenolic acid 12 hours Area Under the concentration-time Curve prediction in Stable renal transplant recipients co-medicated with cyclosporine or sirolimus
Rogier Press Optimizing Calcineurin Inhibitor Exposure In De Novo Kidney Transplant Recipients
Jean Smeets A Mechanism-based Pharmacokinetic Model Describing the Interaction Between Sugammadex and Rocuronium in Patients with Normal and Impaired Renal Function
Tamara van Steeg Assessment of the use of complex baseline models in preclinical safety screening: Application of the van der Pol oscillator model to describe heart rate effects in rats
Johan Wallin Population pharmacokinetics of tacrolimus in paediatric bone marrow transplant recipients
Susan Willavize Dose Selection for Combination Drug Products
Susan Willavize Using M&S to Shorten the Repeating Cycle of the Early Drug Development Process: A Case Study

Methodology- Other topics

Paul Baverel Covariate Model Building Method for Nonparametric Estimation Method in NONMEM VI: Application to Simulated Data
Martin Boucher A Bayesian Meta-Analysis of Longitudinal Data in Placebo Controlled Studies with Naproxen
Marylore Chenel How to show average bioequivalence of concentrations in a test sample with a reference population pharmacokinetic model?
Cian Costello A Time Scaling Approach to Develop an In Vitro-In Vivo Correlation (IVIVC) Model Using a Convolution-Based Technique
Ekaterina Gibiansky Indirect Response Models with Positive Feedback: Equations, Properties, and Possible Applications
Andreas Velsing Groth Alternative parameterisations of saturable (Emax) models allowing for nesting of non-saturable models
Emilie Henin Patient compliance estimated from pharmacokinetic sample: application to Imatinib
Matt Hutmacher Implications for animal-human scaling of the parallel elimination profile PK model
Ibrahim Ince Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling
Ron Keizer A simple infrastructure and graphical user interface (GUI) for distributed NONMEM analysis on standard network environments
Charlotte Kloft Launch of the Graduate Research Training (GRT) Program 'Pharmacometrics & Computational Disease Modelling' in Germany
Ricardo Nalda-Molina Pharmacokinetic and Pharmacodynamic Model for Drug Induced Transient Transaminitis
Carmen Navarro Estimating the complete AUC and its standard error in sparse sampling designs.
Klas Petersson Transforming parts of a differential equations system to difference equations as a method for run-time savings in NONMEM VI
Angelica Quartino Comparison Between using Continuous and Categorical Toxicity Data for Estimation with a Model for Continuous Data
Radojka Savic A novel bootstrap method for obtaining uncertainty measurement around the nonparametric distribution
Nabil Semmar Independent-model diagnostics for a priori identification and interpretation of outliers from a full pharmacokinetic database: correspondence analysis, Mahalanobis distance and Andrews curves
Steven Xu Exposure-Response Analysis of Adverse Events in Clinical Trials Using Zero-Inflated Poisson Modeling With NONMEM®.

Posters Wednesday Afternoon (group II)

Applications- Anti-infectives

Caroline Bazzoli Population pharmacokinetics of AZT and its active metabolite AZT-TP in HIV patients: joint modelling and design optimisation
Helena Colom Population pharmacokinetics of Ganciclovir following Valganciclovir in solid organ transplant recipients infected by cytomegalovirus
Anne Dubois Population analysis of plasma and intracellular pharmacokinetics of indinavir in HIV-1 infected patients with a stable antiretroviral therapy
Monika Frank Nevirapine - Population pharmacokinetic model building and simulation for mothers and newborns
Maria Jose García Population Pharmacokinetics of Efavirenz in HIV-infected patients: Pharmacogenetic analysis
Sylvain Goutelle A Population Pharmacokinetic Study of Plasma and Intrapulmonary Concentrations of Rifampin
Sylvain Goutelle Influence of Rifampin Pharmacokinetic Variability on Antibacterial Effect and Prevention of Resistance in Pulmonary Tuberculosis: a Simulation Study
Flora Musuamba-Tshinanu Simultaneous Therapeutic Drug Monitoring Of Amikacin And Beta-Lactams In Intensive Care Unit Patients With Severe Sepsis Or Septic Shock Without Beta-Lactam Serum Concentration Monitoring
Partha Nandy Relationship Between a PK/PD Parameter and Therapeutic Response of Ceftobiprole in Patients with Complicate Skin and Skin Structure Infection
Michael Neely Population Kinetics and Dynamics of Lopinavir in HIV-Infected Children
Elisabet Nielsen Developmental Pharmacokinetics of Gentamicin in Preterm and Term Neonates: Modelling and Simulation Based on Data from a Prospective Study
Daniel Röshammar Population Pharmacokinetics of Efavirenz and MDR-1, CY2B6, and CYP3A5 Polymorphisms
Catherine Mary Turner Sherwin Simulation and development of a netilmicin extended dosing regimen for extremely premature neonates.
Nicolas Simon Population Pharmacokinetics of Atazanavir in HIV-infected Patients
Joel Tarning Population pharmacokinetics of lumefantrine in pregnant women treated with co-artemether for uncomplicated falciparum malaria
Jan-Stefan van der Walt Population pharmacokinetic models for lamivudine and nevirapine to assess drug concentrations obtained during therapeutic drug monitoring
Wei Zhao Population Pharmacokinetics of Ganciclovir Following Oral Administration of its Prodrug Valganciclovir in Pediatric Renal Transplant Patients

Applications- Coagulation

Xavier Delavenne Assessment of pharmacokinetic variability of fondaparinux in 809 patients treated after major orthopedic surgery: the POP-A-RIX study

Methodology- Design

Massimo Cella Randomisation to exposure in early paediatric trials: an analysis on the influence of the dose on the heterogeneity in the response to abacavir.
Marylore Chenel Optimal design of QTc interval measurements for circadian rhythm determination
Marion Dehez Optimal window design of blood pressure time measurements in hypertensive dippers and non-dippers using ABPM: Application of the compound D-optimality approach.
Phey Yen Han Informative Study Designs to Identify True Parameter-Covariate Relationships
Joakim Nyberg Application of Optimal Design for Disease Progression Studies
Tracy Higgins Simulation and Design Considerations for Noninferiority Trials in Phase II
Hyung Ki Kim The Effect of Study Design on Pharmacokinetics in Patients with Impaired Renal Function
Rocio Lledo Impact of study design for characterising PKPD covariance and nonlinearity in exposure-dichotomous response relationships
Rocio Lledo Randomised dose controlled trials or concentration controlled trials when learning about drugs with narrow therapeutic index?
Mark Lovern Development of a Bayesian Adaptive Sampling Time strategy for PK studies with constrained number of samples to ensure accurate estimates.
Mark Lovern Leveraging complicated PK/PD models for the development of a Bayesian adaptive Dose-ranging design.
Guy Meno-Tetang The Use of Clinical Trial Simulation to investigate Bias in Crossover Studies with a Short Washout Period and no Placebo Arm: Application to Neuropathic Pain
Joakim Nyberg Dose and sample time optimization of drug candidate screening experiments
Kayode Ogungbenro An Effective approach for Obtaining Optimal Sampling Windows for Population Pharmacokinetic Experiments
Italo Poggesi Evaluation of direct population PKPD models for truncated concentration-response curves
Al