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Lewis Sheiner

Budapest, Hungary

Lisboa, Portugal

Hersonissos, Crete, Greece

Alicante, Spain

Glasgow, Scotland

Venice, Italy

Athens, Greece

Berlin, Germany

St. Petersburg, Russia

Marseille, France

KÝbenhavn, Denmark

Brugge/Bruges, Belgium

Pamplona, Spain

Uppsala, Sweden

Verona, Italy

Paris, France

Basel, Switzerland

Salamanca, Spain

Saintes, France

Wuppertal, Germany

Glasgow, Scotland

Sandwich, UK

Frankfurt, Germany

Greenford, UK

Paris, France

Basel, Switzerland

Printable version
Tuesday June 12
18:30-20:30 Reception at City Hall (for registered participants only) at Rådhusplads (link to map)
Wednesday June 13
08:00-09:00 Registration
09:00-09:20 Steen Ingwersen: Welcome and Introduction
09:20-10:20 Stuart Beal Methodology Session

chair: Pascal Girard

09:20-09:40 Robert Bauer Advanced Population Analysis Features in the S-ADAPT/MCPEM Program
09:40-10:00 Fahima Nekka What Additional Information Can we Retrieve When Compliance is Accounted For? An explicit Compliance-Pharmacokinetic Formalism
10:00-10:20 Marc Lavielle The SAEM algorithm and its implementation in MONOLIX 2.1
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 contributions: Applications chair: Mats Karlsson
11:50-12:10 Ashley Strougo Mechanism-based model of the effect of co-administration of exogenous testosterone and progestogens on the hypothalamic-pituitary-gonodal axis in men
12:10-12:30 Joe Standing Developmental Pharmacokinetics of Diclofenac for Acute Pain
12:30-13:30 Lunch
13:30-14:10 Nick Holford: Beginners Tutorial Modeling Disease Progression (link to the presentation and the NONMEM files used
14:10-15:40 Tea break, Poster and Software session II
  Posters in Group II are accompanied by their presenter
15:40-17:30 Modeling Disease and Disease Progression chair: Nick Holford
15:40-16:10 Claudio Cobelli Models of Glucose Metabolism and Control in Diabetes
16:10-16:30 Philippe Jacqmin Basic PK/PD principles of proliferative and circular systems
16:30-16:50 Kim Stuyckens Modeling Drug Effects and Resistance Development on Tumor Growth Dynamics
16:50-17:10 Kristin Karlsson Modelling of disease progression in acute stroke by simultaneously using the NIH stroke scale, the Scandinavian stroke scale and the Barthel index
17:10-17:30 Klaas Prins Integrated Modeling and Simulation of Clinical Response and Drop-out of D2 receptor agonists in Patients with Early Parkinson’s Disease.
Thursday June 14
09:00-10:20 Lewis Sheiner Student Session

chair: France Mentré, Nick Holford, René Bruno, Tim Sheiner

09:00-09:25 Karl Brendel Normalized Prediction Distribution Error for the Evaluation of Nonlinear Mixed-Models
09:25-09:50 S. Y. Amy Cheung Identifiability Analysis and Parameter List Reduction of a Nonlinear Cardiovascular PKPD Model
09:50-10:15 Radojka Savic Importance of Shrinkage in Empirical Bayes Estimates for Diagnostics and Estimation: Problems and Solutions
10:15-10:25 Presentation of Awards  
10:25-11:55 Coffee break, Poster and Software session III
  Posters in Group III are accompanied by their presenter
11:55-12:25 Tim Sheiner: Planning To Communicate
12:25-12:30 Stacey Tannenbaum Preview of American Conference on Pharmacometrics
12:30-13:30 Lunch
13:30-14:30 Marc Buyse Validation of statistically reliable biomarkers
14:30-16:00 Tea break, Poster and Software session IV
  Posters in Group IV are accompanied by their presenter
16:00-17:20 Oral contributions: Applications chair: Charlotte Kloft
16:00-16:20 Celine Dartois Impact of handling missing PK data on PD estimation – explicit modeling of BLQ data in WinBUGS® reduced bias in the PD predictions - a preclinical example.
16:20-16:40 Teun Post Circadian rhythm in pharmacodynamics and its influence on the identification of treatment effects
16:40-17:00 Benoit You Kinetic models of PSA decrease after surgery in prostate tumor diseases as a help for clinician interpretation
17:00-17:20 Justin Wilkins A flexible approach to modeling variable absorption in the context of repeated dosing: illustrated with rifampicin
18:00-24:00 Social evening
Friday June 15
09:00-10:00 Methodology: Design chair: France Mentré
09:00-09:20 Joakim Nyberg Sequential versus simultaneous optimal experimental design on dose and sample times
09:20-09:40 Stefano Zamuner Optimal Design to Estimate the Time Varying Receptor Occupancy Relationship in a PET Experiment
09:40-10:00 France Mentré Software for optimal design in population pharmacokinetics and pharmacodynamics: a comparison
10:00-10:05 Preview of PAGE 2008
10:05-11:05 Coffee break
11:05-12:20 Model Building Session chair: Dinesh de Alwis, Niclas Jonsson 
11:05-11:30 Jeroen Elassaiss-Schaap Interspecies Population Modeling Of Pharmacokinetic Data Available At The End Of Drug Discovery
11:30-11:55 Chantaratsamon Dansirikul Insulin secretion and hepatic extraction during euglycemic clamp study: modelling of insulin and C-peptide data
11:55-12:20 Massimiliano Germani A population PK-PD method for categorical data analysis of progesterone antagonist activity in the rabbit McPhail’s model
12:20-12:30 Steen Ingwersen: Closing Remarks
12:30-12:45 Audience Input for the PAGE 2008 Program

The full program and all abstracts can be downloaded as a single Word document here.

Software demonstrations

Bayer Technology Services
Mango Solutions
NonLinear Mixed Effects Consortium
System for Population Kinetics - David Salinger
USC*PACK and MM-USCPACK - Roger Jelliffe


Posters Wednesday Morning (group I)

Applications- Anti-infectives

Julie Bertrand Influence of pharmacogenetic on pharmacokinetic interindividual variability of indinavir and lopinavir in HIV patients (COPHAR2 – ANRS 111 trial)
Stefanie Hennig Tobramycin in paediatric CF patients - TCI or “One dose fits all”
Déborah Hirt Effect of CYP2C19 polymorphism on nelfinavir to M8 biotransformation in HIV patients.
Hui Kimko Population Pharmacokinetic Analysis To Support Dosing Regimens Of Ceftobiprole
Grant Langdon PK-PD modelling to support go/no go decisions for a novel gp120 inhibitor
Rocio Lledo Population Pharmacokinetics of Saquinavir in rats after IV and IP administration. An approach to Saquinavir/Ritonavir Pharmacokinetic interaction.

Applications- Biologicals/vaccines

Balaji Agoram Application of mechanism-based population PKPD modelling in the rational selection of clinical candidates: an anti-IgE antibody example.
Lene Alifrangis Setting a Safe Starting Dose for a First-in-Man trial of a Monoclonal Antibody Based on Population PK-PD Predictions
Ekaterina Gibiansky Population Pharmacokinetics of Siplizumab (MEDI-507): Implications for Dosing
Ron Keizer Bioequivalence study of a C1-esterase-inhibitor product (Cetor®) with optimised sampling design
Wojciech Krzyzanski Pharmacodynamic Modelling of Recombinant Human Erythropoietin Effect on Reticulocyte Production Rate and Age Distribution in Healthy Subjects
Armel Stockis Population pharmacokinetics of certolizumab pegol

Methodology- Other topics

Johan Areberg Simultaneous Population Pharmacokinetic Modelling of Parent Compound and Metabolite in Plasma and Urine for a New Drug Candidate
Martin Bergstrand A comparison of methods for handling of data below the limit of quantification in NONMEM VI
Robert Bies An MCPEM approach to understanding inter-animal and inter-treatment changes with in vivo striatal dopamine clearance in rats
Sophie Callies Modelling pharmacokinetic and pharmacodynamic properties of second generation antisense-oligonucleotides (ASOs)
Didier Concordet How to estimate population variance matrices with a Prescribed Pattern of Zeros?
Carine Crepin Elimination of anti-epileptic compounds in Marseille aquatic environment from private hospital effluent - modelling versus measurements
Mike Dunlavey Next-Generation Modeling Language
Iñaki F. Trocóniz Modelling Overdispersion and Markovian Features in Count Data
Clare Gaynor An assessment of prediction accuracy of two IVIVC modelling methodologies.
Ihab Girgis Interactive Graphical Visualization Tool for Safety Data Screening
Ihab Girgis Parallel Bayesian Methodology for Population Analysis
Thaddeus Grasela The Application of Systematic Analysis for Identifying and Addressing the Needs of the Pharmacometric Process
Serge Guzy Combining interoccasion variability and mixture within a MCPEM framework
Emilie Hénin Estimation of patient compliance from pharmacokinetic samples
Matt Hutmacher A new approach for population pharmacokinetic data analysis under noncompliance
Matt Hutmacher Comparing Minimum Hellinger Distance Estimation (MHDE) and Hypothesis Testing to Traditional Statistical Analyses – a Simulation Study
Ivan Matthews Sensitivity analysis of a mixture model to determine genotype/phenotype
Chee Meng Ng A Systematical Approach to Bridge the Two-Stage Parametric Expectation Maximization Algorithm and Full Bayesian Three-Stage Hierarchical Nonlinear Mixed Effect Methods in Complex Population Pharmacokinetic/Pharmacodynamic Analysis: Troxacitabine-induced Neutropenia in Cancer Patients
Chee Meng Ng A Comparison of Estimation Methods in Nonlinear Mixed-effect Model for Population Pharmacokinetic-pharmacodynamic Analysis
Stefaan Rossenu A mixture distribution approach to IVIVC modeling of a dual component drug delivery system
Alexander Staab How can routinely collected comedication information from phase II/III trials be used for screening of potential effects on model parameters? A case study with the oral direct thrombin inhibitor Dabigatran etexilate
Stacey Tannenbaum A Comparison of Fixed Dose-Controlled (FD) versus Pharmacokinetic Modified Dose-Controlled (PKMD) Clinical Study Designs
Michel Tod Steady-state Equation for the Bicompartmental Model with Gamma Absorption. Application to Mycophenolate PK in Renal Transplant Patients


Posters Wednesday Afternoon (group II)

Applications- CNS

Emma Bostrom Blood-brain barrier transport helps explain discrepancies in in vivo potency between oxycodone and morphine 
Marc-Antoine Fabre Population pharmacokinetic analysis in children, adolescents and adults with schizophrenia or bipolar disorder
Matt Hutmacher Modeling the Dropout from Longitudinal Adverse Event Data: Selecting Optimal Titration Regimens
Laura Iavarone Population PK/PD of Alprazolam in the Attenuation of ACTH Activation Induced by Cognitive Performance in Metyrapone-treated Healthy Volunteers
Maria Kjellsson Modelling Sleep Using Markov Mixed Effects Models
Frank Larsen Non-Linear Mixed Effects PK/PD Modelling of Acute Autoinhibitory Feedback Effects of Escitalopram (ESC) on Extracellular Serotonin (5-HT) Levels in Rat Brain
Gianluca Nucci Population pharmacokinetic modelling of pimozide and its relation to CYP2D6 genotype.
Gijs Santen Comparing treatment effect in depression trials: Mixed Model for Repeated Measures vs Linear Mixed Model
Armel Stockis Dose-response population modeling of the new antiepileptic drug brivaracetam in add-on treatment of partial onset seizures
Nathalie Toublanc Retrospective population pharmacokinetic analysis of seletracetam in epileptic and healthy adults
Maud Vernaz-Gris Pooled PK analysis of a new CNS drug, in healthy subjects
Sandra Visser Modeling the time-course of the antipyretic effects and prostaglandin inhibition in relation the analgesic effects of naproxen: a compound selection strategy
Katarina Vucicevic Population Pharmacokinetic Modelling of Amitriptyline in Depression Patients
Mathilde Marchand Supporting the recommended paediatric dosing regimen for rufinamide using clinical trial simulation

Methodology- Model evaluation

Mathilde Marchand Population PKPD modelling of biomarkers ANP and big ET-1 for two neutral endopeptidase inhibitors
Julie Antic Evaluation of Non Parametric Methods for population PK/PD
Paul Baverel
Evaluation Of The Nonparametric Estimation Method In NONMEM VI: Application To Real Data
Massimo Cella
Scaling for function: a model-based approach to dosing recommendation for abacavir in HIV-infected children
Emmanuelle Comets
Normalised prediction distribution errors in R: the npde library
Douglas Eleveld
Is the expected performance of a target-controlled-infusion system influenced by the population analysis method
Carlos Fernandez-Teruel
Simulations of bioequivalence trials using physiological-pharmacokinetic models with saturable and non-saturable hepatic clearance
Leonid Gibiansky
Precision of Parameter Estimates: Covariance Step ($COV) versus Bootstrap Procedure
Céline Laffont
Evaluation of model of Heart Rate during Exercise Tolerance Test with missing at random dropouts 
Michael Neely Impact of Lopinavir Limit of Quantification (LOQ)-Censored Data Replacement on Population Pharmacokinetic (PK) Plasma and Saliva Modeling in HIV-Infected Children
Erik Olofsen
The performance of model selection criteria in the absence of a fixed-dimensional correct model
Klas Petersson
Semiparametric distributions with estimated shape parameters: Implementation and Evaluation
Mahesh Samtani
PK/PD Model of Pegylated Thrombopoietin Mimetic Peptide in Healthy Subjects: Comparison of Verification Procedures for Assessing Model Predictability


Posters Thursday Morning (group III)

Applications- Coagulation

Xavier Delavenne The use of an indirect response model to assess interaction between drugs: acenocoumarol and amoxicillin + clavulanic acid
Andreas Velsing Groth A Population PK/PD Model Assessing The Pharmacodynamics Of A Rapid-Acting Recombinant FVII Analogue, NN1731, In Healthy Male Subjects

Applications- CVS

Stefanie Albers Population Pharmacokinetics and Dose Simulation of Carvedilol in Pediatric Patients with Congestive Heart Failure
Kevin Krudys Can Bayes Prevent QTC-interval prolongation? A challenge beyond random effects.
Céline Laffont Population pharmacokinetic analysis of perindoprilat in hypertensive paediatric patients
Divya Menon Pharmacokinetics / Pharmacodynamics of Intravenous Bolus Nicardipine in Adults Undergoing Cardiovascular Surgery

Applications- Oncology

Azucena Aldaz Comparison between NONMEM and NPAG for gemcitabine modelling
Azucena Aldaz
New model for gemcitabine and its metabolites
Gemma Dickinson
Population pharmacokinetics of a novel anticancer drug, RH1, in terminal cancer patients
Yumi Fukushima
Population Pharmacokinetic Analysis of Trastuzumab (Herceptin®) based on Data from Three Different Dosing Regimens
Iztok Grabnar
Population Pharmacokinetics of Methotrexate in Children with Lymphoid Malignancy
Emma Hansson
Modelling of Chemotherapy-induced Febrile Neutropenia using the Predicted Degree and Duration of Myelosuppression
Katharina Küster
Matuzumab – A Population Pharmacokinetic Model and its Evaluation
Ricardo Nalda-Molina
Semi-mechanistic PKPD model for neutropenia using K-PD model in patients receiving high dose of chemotherapy
Ricardo Nalda-Molina
Population Pharmacokinetics of Aplidin® (plitidepsin) in Subjects with Cancer
Dolors Soy Muner
Population Pharmacokinetic Modeling Of Busulfan In Patients Undergoing Autologous Stem Cell Transplantation (ASCT) For Multiple Myeloma
Johan Wallin
Predictive Performance of a Myelosuppression Model for Dose Individualization; Impact of Inter-Occasion Variability and Level and Type of Information Provided

Methodology- Algorithms

Aris Dokoumetzidis An algorithm for proper lumping of systems of ODEs
Jeroen Elassaiss-Schaap
Automation of Structural Pharmacokinetic Model Search in NONMEM: Evaluation with Preclinical Datasets
Serge Guzy
Comparison between NONMEM and the Monte-Carlo Expectation Maximization (MC-PEM) Method Using a Physiologically-Based Glucose-Insulin Model
Robert Leary
A restricted dimensionality nonparametric NLME algorithm
Elodie Plan
Investigation of performances of FOCE and LAPLACE algorithms in NONMEM VI in population parameters estimation of PK and PD continuous data
Benjamin Ribba
Parameters estimation issues for complex population PK models: A Nonmem vs. Monolix study

Methodology- PBPK

Frédérique Fenneteau A Physiologically Based Pharmacokinetic Model to Assess the Role of ABC Transporters in Drug Distribution
Mathilde Marchand
Predicting human from animal PBPK simulation combined with in vitro data
Gianluca Nucci
A Bayesian approach for the integration of preclinical information into a PBPK model for predicting human pharmacokinetics


Posters Thursday Afternoon (group IV)

Applications- Endocrine

Silke Dittberner Determination of the absolute bioavailability of BI 1356, a substance with non-linear pharmacokinetics, using a population pharmacokinetic modelling approach
Daniel Jonker
Pharmacokinetic modelling of the once-daily human glucagon-like peptide-1 analogue, liraglutide, in healthy volunteers and comparison to exenatide
Thomas Klitgaard
Population Pharmacokinetic Model for Human Growth Hormone in Adult Patients in Chronic Dialysis vs. Healthy Subjects
Jean-Marie Martinez
Population Pharmacokinetics of Rimonabant in Obesity
Klaas Prins
Modeling of plasma aldosterone concentrations after prokinetic 5-HT4 receptor agonists: forming an integrated simulation framework for summary statistic and subject-level data

Applications- Other topics

Neil Benson Utility of a mixed effects approach to defining target binding rate constants
Vincent Buchheit
A dedicated SAS Programming Group working in a pharmaceutical Modeling & Simulation organization - Current role, experience and prospects
Joachim Grevel
Evaluation of the population pharmacokinetic properties of lidocaine and its metabolites, MEGX, GX, and 2,6-xylidine, after application of lidocaine 5% medicated plaster
Déborah Hirt
Pharmacokinetic-pharmacodynamic modeling of manganese in patients with acute alcoholic hepatitis after an IV infusion of mangafodipir
Eleanor Howgate
Mechanistic Prediction of HIV Drug-Drug Interactions in Virtual Populations from in vitro Enzyme Kinetic Data: Ritonavir and Saquinavir
Roger Jelliffe
A Population Model of Epidural Lidocaine
Viera Lukacova
PK/PD modeling of Adinazolam – effect of variability of absorption, PK and PD parameters on variability in PD response
Lynn McFadyen
Maraviroc Exposure Response Analysis: Phase 3 Antiviral Efficacy in Treatment Experienced HIV+ Patients
Mark Peterson
Calcium Homeostasis and Bone Remodeling: Development of an Integrated Model for Evaluation and Simulation of Therapeutic Responses to Bone-Related TherapiesRogier Press Dose prediction of tacrolimus in de novo kidney transplant patients with population pharmacokinetic modelling
Catherine Mary Turner Sherwin
A pharmacokinetic/pharmacodynamic model to determine optimal dosing targets for amikacin in neonatal sepsis
Anthe Zandvliet
Dose individualization of indisulam to reduce the risk of severe myelosuppression

Methodology- Design

Anthe Zandvliet Phase I study design of indisulam: evaluation and optimization
Jeff Barrett Improving Study Design and Conduct Efficiency of Event-Driven Clinical Trials via Discrete Event Simulation: Application to Pediatric Oncology
Caroline Bazzoli
Population design in nonlinear mixed effects multiple responses models: extension of PFIM and evaluation by simulation with NONMEM and MONOLIX
Marylore Chenel
Comparison of uniresponse and multiresponse approaches of PopDes to optimize sampling times for drug-drug interaction studies: application to a Servier compound
Marc-Antoine Fabré
Selection of a dosing regimen with WST11 by Monte Carlo simulations, using PK data collected after single IV administration in healthy subjects and population PK modelling
Ivelina Gueorguieva
Prospective application of a multivariate population optimal design to determine parent and metabolite pharmacokinetic sampling times in a Phase II study
Patrick Johnson
Optimal dose and sample-size selection for dose-response studies
Marta Neve
Population methods for dose escalation studies: an MCMC approach
Kayode Ogungbenro
Sample Size Calculations for Repeated Binary Population Pharmacodynamic Experiments
Marcella Petrone
Model-based sequential human PET study design for Optimal PK/RO assessment
Marc Pfister
Optimal Sampling Design and Trial Simulation using POPT and NONMEM
Sylvie Retout
Population designs evaluation and optimisation in R: the PFIM function and its new features