19th PAGE Meeting

  • Berlin - Germany
  • 8-11 June, 2010

Tuesday June 8

16:00-20:00 Registration
18:00-20:00 Welcome reception

Wednesday June 9

08:00-08:45 Registration
08:45-09:00 Welcome and Introduction
09:00-10:20 Physiology based modelling

chair: Charlotte Kloft

09:00-09:40 Wilhelm Huisinga Physiologically-based pharmacokinetic/pharmacodynamic modelling, mathematical model reduction and a mechanistic interpretation of simple empirical models
09:40-10:00 Martin Bergstrand Semi-mechanistic modeling of absorption from extended release formulations - linking in vitro to in vivo
10:00-10:20 Stefan Willmann Investigation of the Influence of CYP3A4 Inhibition and Renal Impairment on Morphine and M6G Formation after Codeine Administration using Coupled Whole-Body PBPK Modelling
10:20-11:50 Coffee break, Poster and Software session I
Posters in Group I (see below) are accompanied by their presenter
11:50-12:30 Physiology based modelling (continued) chair: Katya Gibiansky
11:50-12:10 Pascal Chanu Mechanistic Models to Simulate Dose Response of IgE Suppression Following Dosing of Anti-IgE Monoclonal Antibodies
12:10-12:30 Julia Korell Design of survival studies for red blood cells
12:30-14:00 Lunch
14:00-15:15 Covariate model building chair: Mats Karlsson
14:00-14:55 Stephen Senn Tutorial: Covariate complications in clinical trials
14:55-15:15 Akash Khandelwal Covariate Model Building Using Linear Approximations
15:15-16:30 Tea break, Poster and Software session II
Posters in Group II (see below) are accompanied by their presenter
16:30-17:30 Methodology chair: France Mentré
16:30-16:50 Brigitte Lacroix Evaluating the IPPSE method for PKPD analysis
16:50-17:10 Dalia Khachman You have problems to interpret VPC? Try VIPER!
17:10-17:30 Bruno Boulanger Trial predictions vs. trial simulations in early clinical development: a framework to evaluate the predictive probability of success based on NONMEM outputs

Thursday June 10

08:45-10:05 Lewis Sheiner Student Session

chairs: Chantal Csajka, Ferdie Rombout, Willi Weber

08:45-09:10 Caroline Bazzoli Design evaluation and optimisation in multi-response nonlinear mixed effect models with cost functions: application to the pharmacokinetics of zidovudine and its active metabolite
09:10-09:35 Maud Delattre Estimation of mixed hidden Markov models with SAEM. Application to daily seizures data
09:35-10:00 Lay Ahyoung Lim Dose-response-dropout analysis for somnolence in Pregabalin-treated patients with generalized anxiety disorder
10:00-10:05 Presentation of Awards
10:05-11:20 Coffee break, Poster and Software session III
Posters in Group III (see below) are accompanied by their presenter
11:20-12:20 Clinical applications of PK(PD) chair: Dinesh de Alwis
11:20-11:40 Chao Zhang Population Pharmacokinetics of Lopinavir/Ritonavir in Combination with Rifampicin-based Antitubercular Treatment in HIV-infected Children
11:40-12:00 Jeff Barrett Enhancing Methotrexate Pharmacotherapy in Children with Cancer: A Decision Support System Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records
12:00-12:20 Sarah McLeay Exploring different body-size metric based dosing strategies for propofol in morbidly obese versus healthy weight subjects by modelling and simulation approach
12:20-13:50 Lunch
13:50-15:15 Integrating data with literature chair: Lutz Harnisch
13:50-13:55 Lutz Harnisch Introduction to integrating data with literature
13:55-14:15 Eugene Cox Meta- Analysis of Retention Rates of Post-Marketing Trials to Compare Effectiveness of Second Generation Antiepileptic Drugs
14:15-14:35 Rocío Lledó-García A mechanistic model of the steady-state relationship between HbA1c and average glucose levels in a mixed population of healthy volunteers and diabetic subjects
14:35-15:15 Jonathan French When and how should I combine patient-level data and literature data in a meta-analysis?
15:15-16:30 Tea break, Poster and Software session IV
Posters in Group IV (see below) are accompanied by their presenter
16:30-17:10 Design chair: Marylore Chenel
16:30-16:50 Camille Vong Rapid sample size calculations for a defined likelihood ratio test-based power in mixed effects models
16:50-17:10 Lee Kien Foo D-optimal Adaptive Bridging Studies in Pharmacokinetics
19:00-01:00 Social evening

Friday June 11

09:00-10:00 Stuart Beal Methodology Session chair: Oscar della Pasqua
09:00-09:20 Marc Lavielle Mixture models and model mixtures with MONOLIX
09:20-09:40 Matthew Hutmacher Extending the Latent Variable Model to Non-Independent Longitudinal Dichotomous Response Data
09:40-10:00 Elodie Plan Analysis Approaches Handling Both Symptomatic Severity and Frequency
10:00-10:10 Preview of PAGE 2011
10:10-10:50 Coffee Break
10:50-12:10 PKPD models chair: Nick Holford
10:50-11:10 Sylvain Goutelle Mathematical modeling of pulmonary tuberculosis therapy: development of a first prototype model with rifampin
11:10-11:30 Alberto Russu Integrated model for clinical response and dropout in depression trials: a state-space approach
11:30-11:50 Klas Petersson Predictions of in vivo prolactin levels from in vitro Ki values of D2 receptor antagonists using an agonist-antagonist interaction model
11:50-12:10 Rada Savic Adherence and Population Pharmacokinetics of Atazanavir in Naïve HIV-Infected Patients using Medication Events Monitoring System (MEMS) for drug intake timing
12:10-12:20 Closing Remarks
12:20-12:50 Audience Input for the PAGE 2011 Program

Software demonstrations-Commercial

S_1: Stephane Vellay Pipeline Pilot - Data Integration, Analysis, and Reporting Platform
S_2: Masoud Jamei Simcyp Simulator - a comprehensive platform and database for mechanistic modelling and simulation of drug absorption, tissue distribution, metabolism, transport and elimination in healthy and disease populations using in vitro knowledge
S_3: Sven Janssen SimBiology: A Graphical Environment for Population PK/PD

Software demonstrations-Non-commercial

S_10: Juergen Bulitta Development and Evaluation of a New Efficiency Tool (SADAPT-TRAN) for Model Creation, Debugging, Evaluation, and Automated Plotting using Parallelized S-ADAPT, Perl and R
S_11: Kajsa Harling Xpose and Perl speaks NONMEM (PsN)
S_12: Roger Jelliffe The MM-USCPACK software for nonparametric adaptive grid (NPAG) population PK/PD modeling, and the MM-USCPACK clinical software for individualized drug regimens.
S_13: Ron Keizer Piraña: Open source modeling environment for NONMEM
S_14: Marc Lavielle Analysing population PK/PD data with MONOLIX 3.2
S_15: Sebastian Ueckert PopED - An optimal experimental design software

Posters Wednesday Morning (group I)

Applications- Anti-infectives
I_1: Bambang Adiwijaya Applications of Discrete-Event Dynamic Simulation in HCV Treatment Dynamics
I_2: Jurgen Bulitta Mechanism-based Modelling of the Synergy of Colistin Combinations against Multidrug-Resistant Gram Negative Bacteria
I_4: Emmanuel Chigutsa Parallel first order and mixed order elimination of pyrazinamide in South African patients with tuberculosis
I_5: Isabelle Delattre Population pharmacokinetic modeling and optimal sampling strategy for Bayesian estimation of amikacin in critically ill septic patients
I_6: Oleg Demin Application of systems pharmacology modeling approach to optimize Interferon therapy of hepatitis C
I_7: Thomas Dorlo Optimal Dosing of Miltefosine in Children and Adults with Leishmaniasis

Applications- Biologicals/vaccines
I_8: Marion Dehez Bayesian framework applied to dose escalation studies for biologics
I_9: Amit Garg A Mechanism Based Population Pharmacokinetic-Pharmacodynamic Model for Epoetin Alfa and Darbepoetin Alfa in Chronic Kidney Disease Patients
I_10: Kenneth Luu A Mechanistic Approach to Predicting Human Pharmacokinetics of Monoclonal Antibodies from Preclinical Data: A Case Example
I_11: David Ternant Methotrexate influences neither pharmacokinetics nor concentration-effect relationship of infliximab in axial ankylosing spondylitis
I_12: Pawel Wiczling Pharmacokinetics and Pharmacodynamics of Anti-CD3 Monoclonal Antibody, Otelixizumab, in Subjects with Diabetes and Psoriasis

Applications- CNS
I_13: Neil Attkins Model based analysis of antagonist binding kinetics at CRF-1 receptors in vitro and in vivo
I_14: Marcus Björnsson Modeling of Pain Intensity Measured on a Visual Analogue Scale and Informative Dropout in a Dental Pain Model after Naproxcinod and Naproxen Administration
I_15: Jacob Brogren Transit Compartment Model Useful for Describing Absorption of Quetiapine XR and IR
I_16: Yu-Yuan Chiu Population Pharmacokinetics of Lurasidone in Healthy Subjects and Subjects with Schizophrenia
I_17: Vincenzo Luca Di Iorio Impact of Seizures and Efflux Mechanisms on the Biophase Kinetics and CNS Effects of Anticonvulsant Drugs

Applications- Oncology
I_18: Nicolas Azzopardi Pharmacokinetics and concentration-effect relationship of cetuximab in metastatic colorectal cancer
I_19: Anne Drescher Pharmacokinetic/Pharmacodynamic Modeling of Platinum-DNA-Adduct Formation in Leukocytes after Oxaliplatin Infusion
I_20: Jeroen Elassaiss-Schaap Allometric scaling in oncology disease progression from xenograft tumor growth to human non-small-cell lung cancer
I_21: Iñaki F. Trocóniz Predictive ability of a semi-mechanistic model for neutropenia in the development of novel anti-cancer agents: two case studies using diflomotecan and indisulam
I_22: Ron Keizer Evaluation of clinical dosing of E7820 from preclinical and clinical data using a biomarker

Applications- Other topics
I_23: Claire Ambery Leveraging biomarker exposure-response in drug development
I_24: Jacqueline Anderson PK modelling of organophosphorus poisoning in humans
I_25: Massoud Boroujerdi Joint model for dropout in longitudinal trials in COPD patients
I_26: Karl Brendel Population pharmacokinetics-pharmacodynamics modeling of the QTc prolongation of Moxiflovoxacin and Levofloxacin in healthy volunteers: selection of the positive control in mandatory QT/QTc studies
I_27: Karl Brendel Using Modelling & Simulation techniques to optimise the design of a paediatric PK/PD study
I_28: Sophie Callies Integration of preclinical data to support the design of the first in-man study of LY2181308, a second generation antisense oligonucleotide.
I_29: Roosmarijn De Cock Predicting glomerular filtration rate using clearance of amikacin
I_30: Oleg Demin Jr Can systems modeling approach be used to understand complex PK-PD relationships? A case study of 5-lipoxygenase inhibition by zileuton
I_31: Pinky Dua SB-773812: Correlation between in-silico and in-vivo metabolism

Methodology- Model evaluation
I_32: Roberto Bizzotto Multinomial logistic functions in Markov-chain models for modeling sleep architecture: external validation and covariate analysis
I_33: Roberto Bizzotto PK-PD modeling of Wake after Sleep Onset time-course
I_34: Roberto Bizzotto Multinomial logistic functions in Markov-chain models for modeling sleep architecture: internal validation based on VPCs
I_35: Emmanuelle Comets Using simulations-based metrics to detect model misspecifications
I_36: Didier Concordet A new solution to deal with eta-shrinkage: the Weighted EBEs!
I_37: Paul Matthias Diderichsen<a href="../?abstract=18