2006 - Brugge/Bruges - Belgium

2006 - Brugge/Bruges - Belgium

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