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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
Wednesday June 14
12:00-14:00 Registration and light lunch
14:00-14:15 Welcome and Introduction
14:15-14:45 Paolo Vicini The population approach identity crisis: The search for innovation in modeling and simulation
14:45-15:15 Tom Ludden and Alison Boeckmann A tribute to Stuart Beal (link to Tom's and Alison's presentation)
15:15-15:45 Coffee/tea break
15:45-16:45 Stuart Beal Methodology Session chair: Tom Ludden and Alison Boeckmann
15:45-16:05 Radojka Savic Evaluation of the nonparametric estimation method in NONMEM VI beta
16:05-16:25 Matt Hutmacher Model selection using the Minimum Hellinger Distance Criterion (MHDC) with an introduction to Minimum Hellinger Distance Estimation (MHDE)
16:25-16:45 Andrew Hooker Conditional weighted residuals, an improved model diagnostic for the FO/FOCE methods
16:45-17:00 Short break
17:00-17:40 Oral contributions: Pharmacogenetics

chair: Alison Thomson

17:00-17:20 Doaa Elsherbiny Modeling of the induction of CYP2B6 and CYP2C19 by artemisinin antimalarials
17:20-17:40 Andrea Edginton Determining the effect of CYP2C9 genotypes on diclofenac metabolism using individualized coupled physiology-based pharmacokinetic modeling
Thursday June 15
09:00-10:20 Model Building Session

chair: Mats Karlsson and Steve Duffull

09:00-09:15 Celine Dartois How is model building reported for population PK-PD? An exhaustive survey of the literature between 2002 and 2004
09:15-09:30 Karl Brendel Are population PK/PD models adequately evaluated? An exhaustive survey of the literature between 2002 and 2004
09:30-09:55 Didier Renard Bayesian hierarchical modeling of receptor occupancy in PET trials
09:55-10:20 Jan van Eijkeren Model building and model parameter identification for transfer of dioxin TEQs from feed to eggs
10:20-11:50 Coffee break, Poster and Software session I
  Posters in Group I are accompanied by their presenter (see below)
11:50-12:30 Oral contributions: Applications in model based drug development (I) chair: Oscar Della Pasqua 
11:50-12:10 Thaddeus Grasela Challenges in the transition to model-based development
12:10-12:30 Amit Roy Optimizing dose selection with respect to multiple safety/efficacy endpoints using clinical utility concepts
12:30-13:30 Lunch
13:30-14:10 Oral contributions: Applications in model based drug development (II)

chair: Mick Looby

13:30-13:50 Ekaterina Gibiansky Model-based drug development: optimization of Aquavan® injection dosing for minimal-to-moderate sedation
13:50-14:10 Ken Kowalski A modeling and simulation case study: impact on an early clinical development program
14:10-15:40 Tea break, Poster and Software session II
  Posters in Group II are accompanied by their presenter (see below)
15:40-17:00 Modelling oral absorption session chair: Achiel van Peer 
15:40-16:00 Mats Karlsson Overview of oral absorption models and modelling issues
16:00-16:20 Stefan Willmann Simulating oral absorption with PK-Sim®: Methodology and application examples
16:20-16:40 Amin Rostami-Hodjegan Complications in assessing the hepatic first-pass component of bioavailability
16:40-17:00 Walter Woltosz Simulation of the nonlinear PK of Gabapentin and Midazolam in adult and pediatric populations
17:00-17:15 PAGE and the web-page, planning of future PAGE meetings, preview PAGE 2007
19:00-24:00 Social Evening  
Friday June 16
  Lewis Sheiner Student Session chair: Jean-Louis Steimer and Ted Grasela
09:00-09:25 Emilie Hénin A KDP model for ordered categorical data: application to toxicity score in colorectal cancer patients treated with capecitabine
09:25-09:50 Adeline Samson The SAEM algorithm for non-linear mixed models with left-censored data and differential systems: application to the joint modeling of HIV viral load and CD4 dynamics under treatment
09:50-10:15 Anthe Zandvliet Semi-mechanistic PK/PD model of indisulam in combination with capecitabine: a time-dependent pharmacokinetic interaction contributes to excessive hematological toxicity
10:15-11:45 Coffee break, Poster and Software session III
  Posters in Group III are accompanied by their presenter (see below)
11:45-12:45 Geert Verbeke Mixed models for the analysis of categorical repeated measures
12:45-13:45 Lunch
13:45-14:45 Oral contributions: Applications chair: Pascal Girard 
13:45-14:05 John Mondick Acknowledging parameter uncertainty in the simulation-based design of an Actinomycin-D pharmacokinetic study in pediatric patients with Wilms' tumor or rhabdomyosarcoma
14:05-14:25 Anders Viberg Individualization of Cefuroxime dosage using pharmacodynamic targets, MIC distributions and minimization of a risk function
14:25-14:45 Fabienne Thomas Cystatin C as a new covariate to predict the renal elimination of drugs
14:45-16:15 Tea break, Poster and Software session IV
  Posters in Group IV are accompanied by their presenter (see below)
16:15-16:55 Oral contributions: Methodology chair: France Mentré 
16:15-16:35 Jakob Ribbing The LASSO - A novel method for predictive covariate model building in nonlinear mixed effects models
16:35-16:55 Serge Guzy Monte Carlo parametric expectation maximization (MC-PEM) method for analyzing population PK/PD data
16:55-17:00 Concluding remarks





Software demonstrations


S-01. Marc Lavielle Analysing population PK/PD data with the MONOLIX software
S-02. Pontus Pihlgren Transforming a set of office computers to a computing cluster.
S-03. Sylvie Retout New features for population designs evaluation and optimisation in R: PFIM 2.0 and PFIMOPT 2.0
S-04. Justin Wilkins Xpose – an R-based population pharmacokinetic/pharmacodynamic model-building aid for NONMEM
S-05. Roger Jelliffe The USC*PACK BigWinPops and MM-USCPACK Software
S-06. Paolo Vicini The System for Population Kinetics (SPK)


S-07. Stefan Willmann Hands-On Demonstrations of the Physiology-Based Pharmacokinetic Software, PK-Sim®
S-08. Serge Guzy The PDX-MC-PEM software
S-09. ICON Development solutions Hands-On Demonstration of PDx-Pop® v2.0; Tools for Expediting Population Analysis
S-10. Mango Solutions Mango solutions
S-11. SimulationsPlus GastroPlus
S-12. Simcyp Ltd Simcyp - a platform for simulation and prediction of in vivo drug disposition in virtual human populations
S-13. Sundararajan Vijayakumar
iClinical: NONMEM Workbench


Posters Thursday Morning (group I)

Applications- Anti-infectives

I-01. René Bruno Modeling and Simulation of DEBIO-025 to Support Design of a Dose-Response Monotherapy Study in HIV-1 infected Patients
I-02. Jurgen Bulitta Bias and Uncertainty of Monte Carlo Simulations with Beta-Lactams
I-03. Laurent Claret Therapeutic modelling and analysis of random feeding features of feed-administered chlortetracycline
I-04. Helena Colom Population pharmacokinetics of Valganciclovir in solid organ transplant recipients infected by cytomegalovirus
I-05. Manish Gupta Optimizing Fluconazole Dosing in Preterm Neonates Based on Simulations from Posterior Parameter (Uncertainty) Distributions
I-06. Stefanie Hennig Paediatric population pharmacokinetics of itraconazole and its active metabolite hydroxy-itraconazole in cystic fibrosis and bone marrow transplant patients
I-07. Cornelia Landersdorfer New Insights into the Most Commonly Studied Drug Interaction with Antibiotics: Pharmacokinetic Interaction between Ciprofloxacin, Gemifloxacin and Probenecid at Renal and Non-renal Sites
I-08. Elisabet Nielsen Population Pharmacokinetics of Gentamicin in Preterm and Term Newborn Infants
I-09. Nele Plock A Population Pharmacokinetic Model for the Simultaneous Description of Linezolid Tissue and Plasma Disposition in Healthy Volunteers and Septic Patients
I-10. Peter Vis Development and application of a population pharmacokinetic model of TMC114 in healthy volunteers and HIV-1 infected subjects after administration of TMC114 in combination with low dose ritonavir
I-11. Dong-Seok Yim Population pharmacokinetics of meropenem in febrile neutropenic patients in Korea

Applications- Biologicals/vaccines

I-12. Ivan Nestorov Population modeling of the relationship between TACI Ig exposure and biomarker response in patients with rheumatoid arthritis (RA)
I-13. Juan Jose Perez Ruixo Optimizing the Design of Phase I Studies of Erythropoietin Receptor Agonist Through Mechanism-Based PK/PD Modeling and Simulation

Applications- CNS

I-14. Mohammed Al Zaabi Use of Routine Data for Determination of the Population Pharmacokinetics and Enteral Bioavailability of Phenytoin in Neonates and Infants with Seizures
I-15. Emma Bostrom In vivo blood-brain barrier transport of oxycodone in the rat – active influx and implications for PK/PD
I-16. Lena Friberg A mechanism-based pharmacokinetic-pharmacodynamic model of the time-course of prolactin following antipsychotic drug treatment
I-17. Thorsten Lehr Population pharmacokinetics of NS2330 and its major metabolite in Alzheimer’s disease patients
I-18. Thorsten Lehr Efficacy modelling of NS2330 in mild Alzheimer’s disease patients
I-19. Scott Marshall Application of PK/PD modelling in the development eletriptan DR for the treatment of acute migraine and prevention of headache recurrence.
I-20. Ivan Matthews Pharmacokinetics of a single bolus of propofol in Chinese children of different ages
I-21. Raymond Miller Comparision of Pregabalin and Gabapentin Pharmacodynamics in Patients with Refractory Partial Seizures.
I-22. Ignacio Ortega Concentration-response analysis of antipsychotic drug effects using an indirect response model
I-23. Olivier Petricoul Extrapolation from preclinical PKPD data to clinical response, Application to a new antiepileptic medication (drug X)
I-24. Maria Laura Sargentini-Maier Population pharmacokinetics of the new antiepileptic drug brivaracetam
I-25. Marta Valle Population Pharmacokinetic-Pharmacodynamic modelling of olanzapine effects on the electroencephalogram in healthy volunteers.

Posters Thursday Afternoon (group II)

Applications- Coagulation

II-01. Stephanie Chantel Pharmacokinetic variability of the absorption of enoxaparin used subcutaneously for venous thromboembolism prophylaxis
II-02. Anne Paccaly Non-Linear Population Pharmacokinetic Model for Otamixaban in Healthy Male Subjects

Applications- CVS

II-03. Karin Tunblad The use of clinical irrelevance criteria in covariate model building with application to dofetilide pharmacokinetic data

Applications- Endocrine

II-04. Damien Cronier Modelling of insulin secretion: from beta-cell physiology to sulphonylurea-mediated insulin secretion
II-05. Silke Dittberner Pre-Clinical PK/PD Modeling for a Dipeptidyl Peptidase-IV Inhibitor
II-06. Mats Karlsson Mechanism-based pharmacokinetic and pharmacodynamic modelling of tesaglitazar in type 2 diabetes patients
II-07. Richard Mills Simultaneous fitting of the Minimal Model to IVGTT and Glucose Clamp Data
II-08. Jean-Louis Steimer Population pharmacokinetics of balicatib, a cathepsin K inhibitor
II-09. Jean-Louis Steimer PKPD model for cathepsin K inhibition with balicatib and changes in bone turnover biomarkers, in particular NTx

Applications- Oncology

II-10. René Bruno A longitudinal model for tumor size measurements in clinical oncology studies
II-11. Michael Dodds Population pharmacodynamic model of the effects of recombinant human interleukin 21 on platelets in humans
II-12. Georg Hempel A Population Model Describing the Activity-time Course of Pegylated Asparaginase in Children
II-13. Jeremy Hing Population PK/PD Modelling & Simulation of Hematological Toxicity of Trabectedin in Cancer Subjects
II-15. Katharina Küster Population Pharmacokinetic Analysis for Matuzumab (EMD 72000) – A Humanised EGFR-Targeted Monoclonal Antibody
II-16. Angelica Quartino A simultaneous analysis of the time course of leukocytes and neutrophils following docetaxel administration using a semi-mechanistic model
II-17. Amelia Ramón-López Semi-mechanistic KPD model for haematological toxicity in breast cancer patients receiving high dose of chemotherapy
II-18. Johan Wallin An Adaptive Dosing Tool For Etoposide Using Neutrophil Counts Based on a Semi-Physiological Model
II-19. Demiana William Population pharmacokinetic study of methotrexate in patient with lymphoid malignancy
II-20. Anthe Zandvliet Pharmacogenetically guided dosing of the anticancer agent indisulam normalizes the risk of severe hematological toxicity

Posters Friday Morning (group III)

Applications- Other topics

III-01. Marion Dehez Population modeling approach of circadian blood pressure variations using ambulatory monitoring in dippers and non dippers
III-02. Markus Joerger Epirubicin pharmacokinetics-pharmacodynamics and metabolic pathway-associated gene polymorphisms: Significant influence of the novel UDP-glucuronosyltransferase 2B7 promoter mutation -66T>C
III-03. Elsa López Pintor Population pharmacokinetics approach for salbutamol sulphate in rats
III-04. Mark Lovern Using a Placebo Response Model to Optimize Clinical Trial Designs for Irritable Bowel Syndrome (IBS) Therapies
III-05. Annick Rousseau Population pharmacokinetics and Bayesian estimation of mycophenolate mofetil in paediatric renal transplant recipients using a non-parametric approach.
III-06. Annick Rousseau Population pharmacokinetics of sirolimus in adult renal transplant patients and Bayesian estimation of individual systemic exposure
III-07. Takeshi Tajima Population approach to assess the relationship of cyclosporin exposure and renal dysfunction in Japanese patients with rheumatoid arthritis
III-08. Reinier van Hest Pharmacokinetic modeling of plasma protein binding of mycophenolic acid in renal transplant recipients

Methodology- Algorithms

III-10. Emmanuelle Comets Analysis of digoxin data using Non-Parametric Maximum Likelihood (NPML)
III-11. Leonid Gibiansky R/NONMEM Toolbox for Simulation from Posterior Parameter (Uncertainty) Distributions
III-12. Robert Leary Parallel Processing for Nonlinear Mixed Effects Modeling
III-13. Carmen Navarro Sparse sampling designs using small animals: a new method for estimating the complete AUC and its variability
III-14. Erik Olofsen Using the Lasso to simultaneously identify the covariate and variance-covariance structures of nonlinear mixed-effects models
III-15. Xavière Panhard Extension of the SAEM algorithm for the estimation of Inter-Occasion Variability: application to the population pharmacokinetics of nelfinavir and its metabolite M8

Methodology- Design

III-16. Barbara Bogacka Efficient Sampling Windows for Parameter Estimation in Population Models
III-17. Stephen Duffull Bayesian Estimation of Optimal Sampling Times for Pharmacokinetic Models
III-18. Stefanie Hennig A D-optimal designed population pharmacokinetic study of itraconazole capsules and solution in adults with cystic fibrosis
III-19. Diane Testart Assess Nonmem® fitness of purpose regarding parameters estimation in the context of a preclinical toxicological study.

Posters Friday Afternoon (group IV)

Methodology- Model evaluation

IV-01. Chantaratsamon Dansirikul Comparison of models for baseline
IV-02. Nick Holford NONMEM Termination Status is Not an Important Indicator of the Quality of Bootstrap Parameter Estimates
IV-04. Lars Lindbom Evaluating the evaluations: resampling methods for determining model appropriateness in pharmacometric data analysis
IV-05. Ivan Matthews A population pharmacokinetic model for s-warfarin: application of a mixture model to determine genotype/phenotype.
IV-06. Ricardo Nalda-Molina A simple physiological-pharmacokinetic model to simulate bioequivalence trials
IV-07. Teun Post Accurate Interpretation of the Visual Predictive Check in order to Evaluate Model Performance
IV-08. Hanna Silber The likelihood ratio test appears robust to most residual error model misspecifications
IV-09. Justin Wilkins Patterns and power for the visual predictive check

Methodology- Other topics

IV-10. Julie Bertrand Detecting a gene effect in pharmacokinetic models: comparison of different methods
IV-11. Kristin Cecilie Carlsson Mixture models in NONMEM - how to find the individual probability of belonging to a specific mixture, and why this can be useful information
IV-12. Aris Dokoumetzidis Direct application of Bayes theorem for the combination of population pharmacokinetic analyses.
IV-13. Clare Gaynor Comparison of conventional In Vitro - In Vivo Correlation methodology with non-linear mixed effects modelling
IV-14. Matt Hutmacher An extension of the indirect response models to ordered categorical pharmacodynamic data using latent variables
IV-15. Thorsten Lehr PROPHET - A convenient and efficient environment for the use of NONMEM in a global pharmaceutical company
IV-16. Pierre Roy Is it possible to perform equivalent simulations with NONMEM and TS2?
IV-17. Eric Tousset Relation between patients’ variable compliance and office blood pressure in treatment-resistant hypertension.
IV-18. Barry Weatherley Population Analysis of Maraviroc Phase 1 Noncompartmental Pharmacokinetic Data

Methodology- PBPK

IV-19. Andrea Edginton Use of a physiology-based whole-body population model to simulate the influence of anthropometric-, clearance-, and physiological-variance on the pharmacokinetics of drugs
IV-20. Grant Langdon Linking preclinical and clinical whole body physiologically-based pharmacokinetic models with prior distributions in NONMEM
IV-21. Clare Rodrigues Norfloxacin – a whole body physiologically based pharmacokinetic model