| Tuesday June 23 | |||
| 10:00-18:00 | Registration | ||
| 19:00-20:00 | Opening ceremony | ||
| 20:00-22:00 | Welcome cocktail | ||
| Wednesday June 24 | |||
| 08:00-08:45 | Registration | ||
| 08:45-09:00 | Welcome and Introduction | ||
| 09:00-10:05 | Paediatric Session: Are children Small Adults? |
chair: Alison Thomson and Nick Holford |
|
| 09:00-09:30 | Brian Anderson, Catherijne Knibbe and Willem de Winter | ||
| 09:30-10:05 | Panel discussion | ||
| 10:05-11:35 | Coffee break, Poster and Software session I | ||
| Posters in Group I are accompanied by their presenter | |||
| 11:35-12:15 | Paediatric session continued (submitted abstracts) | chair: Alison Thomson and Nick Holford | |
| 11:35-11:55 | Michael Looby | Elucidation of the Optimal Dosing Scheme of an Antiviral Drug in Children | |
| 11:55-12:15 | Lutz Harnisch | Population PK of Sildenafil and PK/PD Assessment of Exercise Tolerability in Children with Pulmonary Arterial Hypertension (PAH) | |
| 12:15-13:45 | Lunch | ||
| 13:45-15:05 | Model Building and Evaluation | chair: Mats Karlsson | |
| 13:45-14:05 | Chuanpu Hu | Confirmatory Phase III Population Pharmacokinetic Analysis | |
| 14:05-14:25 | Julie Bertrand | Model-based Tests to Detect Gene Effect in Pharmacokinetic Studies | |
| 14:25-14:45 | Céline Laffont-Rousset | A New Exact Test to Globally Assess a Population PK and/or PD Model | |
| 14:45-15:05 | Diane Wang | Standardized Visual Predictive Check - How and When to Use it in Model Evaluation | |
| 15:05-16:20 | Tea break, Poster and Software session II | ||
| Posters in Group II are accompanied by their presenter | |||
| 16:20-17:40 | PK and PD in Oncology | chair: Dinesh De Alwis | |
| 16:20-16:40 | Ron Keizer | Modeling of Hypertension in Response to Anti-angiogenic Therapy | |
| 16:40-17:00 | Benjamin Ribba | Estimating the Kinetic Parameters of Vascular Tumor Growth Models to Optimize Anti-angiogenesis Drugs Delivery | |
| 17:00-17:20 | Vladimir Vainstein | Targeted Drug Delivery by Gemtuzumab Ozogamicin: Mechanism-based Pharmacokinetic Model for Treatment Strategy Improvement and Prediction of Individual Responses. | |
| 17:20-17:40 | David Ternant | Model-based Optimization of Rituximab Dosing Regimen in Follicular non-Hogdkin Lymphoma | |
| Thursday June 25 | |||
| 08:45-10:05 | Lewis Sheiner Student Session |
chairs: Charlotte Kloft/ Iñaki Trocóniz/ Oscar Della Pasqual |
|
| 08:45-09:10 | Julie Antic | Nonparametric Methods: When to Use Them? Which Method to Choose? | |
| 09:10-09:35 | Venkata Pavan Kumar Vajjah | Novel Graphical Diagnostics for Assessing Fit of Logistic Regression Models | |
| 09:35-10:00 | Elena Soto | Prediction of Haematological Effects of a New Combination of Anticancer Drugs, BI 2536 (a PLK1 Inhibitor) and Pemetrexed, Using a Semi-mechanistic Population Model for Neutropenia | |
| 10:00-10:05 | Presentation of Awards | ||
| 10:05-11:20 | Coffee break, Poster and Software session III | ||
| Posters in Group III are accompanied by their presenter | |||
| 11:20-12:20 | Mechanistic Modelling | chair: Stephen Duffull | |
| 11:20-11:40 | Willem de Winter | Integrating a Model for Weight Change into the Mechanism-Based Model for Type 2 Diabetes | |
| 11:40-12:00 | Rocío Lledó-García | Modeling of Red Blood Cell (RBC) Lifespan (LS) in a Hematologically Normal Population | |
| 12:00-12:20 | Andreas Kuttler | A 3D Computational Model of Cerebrospinal Fluid Dynamics for Predictive Biosimulation | |
| 12:20-13:50 | Lunch | ||
| 13:50-14:35 | Valeri Fedorov and Ivelina Gueorguieva: Tutorial on Optimal Design in Population PKPD Analyses | ||
| 14:35-15:15 | Optimal Design | chair: Marylore Chenel | |
| 14:35-14:55 | Nathalie Gobeau | Comparison of Different Tools for the Optimization of a Pediatric Clinical Trial | |
| 14:55-15:15 | Joakim Nyberg | Population Optimal Experimental Design for Discrete Type Data | |
| 15:15-16:30 | Tea break, Poster and Software session IV | ||
| Posters in Group IV are accompanied by their presenter | |||
| 16:30-17:10 | Time to Event Modelling | chair: Lutz Harnisch | |
| 16:30-16:50 | Andrew Hooker | Time to Event Modeling of Dropout Events in Clinical Trials | |
| 16:50-17:10 | Nick Holford | The Influence of the Time Course of CD4 and Viral Load on Clinical Outcome Events Before and During Antiretroviral Therapy | |
| 19:00-24:00 | Social evening Important note: Buses depart at 18.00 h from St. Petersburg Hotel and at 18:15 h from the other selected hotels. Participants must depart from the hotel where they are staying as buses have been allocated according to reservation details. |
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| Friday June 26 | |||
| 09:00-10:00 | Stuart Beal Methodology Session | chair: France Mentré | |
| 09:00-09:20 | Birgitte Rønn | Maximum Likelihood Estimation in Nonlinear Mixed Effect Models: Adaptive Gaussian Quadrature by Sparse Grid Sampling | |
| 09:20-09:40 | Matthew Hutmacher | Estimating Transformations for Population Models of Continuous, Closed Interval Data | |
| 09:40-10:00 | Radojka Savic | A New SAEM Algorithm for Ordered-categorical and Count Data Models: Implementation and Evaluation | |
| 10:00-10:30 | Robert Bauer | Improvements and New Estimation Methods in NONMEM 7 for PK/PD Population Analysis | |
| 10:30-11:10 | Coffee Break | ||
| 11:10-11:20 | Preview of PAGE 2010 | ||
| 11:20-12:20 | Methodology and applications in PK (TK/TD) studies | chair: Oscar Della Pasqua | |
| 11:20-11:40 | Fran Stringer | Genotyped Versus Phenotyped Dosing to Account for UGT Polymorphism of the Novel PPAR Agonist Sipoglitazar | |
| 11:40-12:00 | William Denney | Modeling and Simulation for Determination of the Therapeutic Window of MK-2295: a TRPV1 Antagonist | |
| 12:00-12:20 | Billy Amzal | Population TK/TD for Chemical Risk Assessment and Drug Safety: the Cadmium Example | |
| 12:20-12:30 | Closing Remarks | ||
| 12:30-12:45 | Audience Input for the PAGE 2010 Program | ||
Software demonstrations
Balaji Agoram PulmoSim: A Physiologically-Based Mathematical Model Software Package to Predict Lung Retention and Inhaled Pharmacokinetics of Therapeutic Candidates
William J. Bachman PDx-Pop® 4 for NONMEM® 7
Caroline Bazzoli New features for population design evaluation and optimization with R functions: PFIM Interface 3.1 and PFIM 3.2
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.
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.
Marc Lavielle Analysing population PK/PD data with MONOLIX 3.1
Piet van der Graaf A4S: a user-friendly PKPD simulation software for non experts
Stephane Vellay Pipeline Pilot - Data Integration, Analysis, and Reporting Platform
Justin Wilkins Census: NLME project management for NONMEM
Pharsight Corporation Phoenix NLME and Phoenix
Posters Wednesday Morning (group I)
Applications- Other topics
001. Claire Ambery Population PK-PD Modelling of Wheal and Flare Area in a First-Time-in-Human Study
005. Kyle Baron Evaluation of Assumptions in the Clinical Use of the Cockcroft-Gault Equation
009. Martin Bergstrand Semi-mechanistic PK/PD modeling of Paracetamol and Sulfapyridine to characterize effects on gastric emptying and small intestinal transit
013. Dmitry Bordin Relating Pharmacokinetics and Pharmacodynamics of Proton Pomp Inhibitors (Ppis) to Clinical Performance in Patients with Gastroesophageal Reflux Disease (GERD)
017. Jonathan French Safety monitoring of a kidney transplant study using a Bayesian time-to-event model
021. Iztok Grabnar Population Pharmacokinetics of the Active Metabolite of Leflunomide in Patients with Rheumatoid Arthritis
025. Thaddeus Grasela Improving the Efficiency and Ensuring the Quality of Data Assembly for Pharmacometric Analysis
029. Roger Jelliffe Optimal Stochastic Control Of Drug Dosage Regimens
033. Patrick Johnson Enhanced quantitative drug development (EQDD) of a selective PDE5 inhibitor for the treatment of benign Prostatic hyperplasia (BPH).
037. Helene Karcher Interpreting QT in a Patient Population After Surgical Intervention
041. Andreas Kuttler A 3D mechanical model of the gastric esophageal junction: model-based assessment of muscle stretch tension in the gastric smooth muscle with emphasis to reflux disease
045. Lia Liefaard Modelling non-linear dose-dependent absorption profiles after oral prolonged release formulations
049. Igor Locatelli Population Pharmacokinetic Analysis of Silymarin Bioavailability in Rats
053. Guangli Ma Quantifying Lung Function Progression in Asthma
057. Sven Mensing Markov Modeling of Side Effect Related Dropout Rates by Introduction of Previous State Memory
061. Flora Musuamba-Tshinanu Time of Drug Administration, Genetic Polymorphism and Analytical Method Influence Tacrolimus Pharmacokinetics: A Population Pharmacokinetic Approach
065. Flora Musuamba-Tshinanu Multivariate and Population Pharmacokinetic Analyses for Tacrolimus Area Under The Concentration-Time Curve Prediction in De Novo Renal Transplant Recipients
069. Davinia Oltra-Noguera Population pharmacokinetics of Ropivacaine and Bupivacaine after loco-regional administration as anesthetic in hip or knee replacement surgery.
073. Ines Paule Population Pharmacokinetics and Pharmacodynamics of Hydroxyurea in Sickle Cell Anemia Patients, In Silico Comparison of Two Dosing Regimens
077. Gregory Pinault Quality, Efficiency and Industrialisation Initiatives during the evolution of a dedicated SAS Programming Group
081. Rogier Press Is Calcineurin Activity Useful as a Biomarker to Optimize Cyclosporine A Therapy in Renal Transplant Recipients?
085. Klaas Prins Use of model based meta-analysis combining patient-level with summary-level data using multilevel random effects to provide a quantitative assessment of the clinical efficacy (IPSS) profile and competitive positioning of a PDE5 inhibitor (UK369,003) for the treatment of benign prostatic hyperplasia (BPH).
089. Nelleke Snelder Safety pharmacology screening using a standardized population pharmacokinetic pharmacodynamic modelling approach
093. Joe Standing Population Pharmacokinetic Modelling of Esomeprazole Nonlinearity
097. Charlotte van Kesteren Prediction of drug effects using a longitudinal turnover model for FEV1 in patients with chronic obstructive pulmonary disease (COPD).
101. Jason Williams Bayesian Network Approach to Modeling Spinal Muscular Atrophy Populations
Methodology- Other topics
105. Paul Baverel Comparison of two PsN Bootstrapping Routines for Obtaining Uncertainty Measurement around the Nonparametric Distribution Obtained in NONMEM VI
109. Aliénor Bergès An Efficiency Comparison between Concentration-Response Analysis and Dose-Response Analysis through Simulation
113. Massoud Boroujerdi A turnover longitudinal model for the analysis of FEV1 changes in COPD
117. Phylinda Chan Population Pharmacokinetic-Pharmacodynamic-Viral Dynamics Modelling of Maraviroc Monotherapy Data Using MONOLIX
121. Jeroen Elassaiss-Schaap Variability as constant coefficient of variation: Can we right two decades in error?
125. Leonid Gibiansky Pharmacodynamic Modeling of Biologics with Target-Mediated Drug Disposition: TMDD Approximations, Relation to Indirect-Response Models, and Application to Population PK-PD Analyses
129. Varun Goel A Bayesian Multivariate Model for Repeated Measures of Correlated Data
133. Sylvain Goutelle Performing Monte Carlo Simulation Based on Nonparametric Pharmacokinetic Parameter Distributions: Evaluation of Various Methods Applied to a Paediatric Population Study on Busulfan
137. Emilie Henin Tablet position in gastrointestinal tract derived from drug release measurements and plasma concentrations
141. Ibrahim Ince Population PK modeling of Midazolam in Infants, the effect of age and other covariates
145. Hester Kramer Phase II dose selection for a hypothetical novel Direct Thrombin Inhibitor (DTI): an integrated approach using experimental and literature data.
149. Brigitte Lacroix Implementation of a NONMEM cluster and add-ons within UCB
153. Hugh McDevitt Infrastructure development for building, maintaining and modeling indication- specific summary-level literature databases to support model based drug development.
157. Carmen Navarro Bioequivalence Trials Simulation to Select the Best Analyte for Drugs with Presystemic Intestinal and Hepatic Metabolism.
161. Didier Renard Using desirability indices for decision making in drug development
165. Soundos Saleh Matching PBPK and NONMEM pharmacokinetics descriptions to understand and extrapolate - case study ciprofloxacin
169. Nelleke Snelder A proposal for implementation of the Markov property into a continuous time transition state model in NONMEM
173. Ashley Strougo Mechanism-based pharmacokinetic modelling to describe the effect of protein binding on the pharmacokinetics of solifenacin
177. Dalia Vasquez Population Pharmacokinetic-pharmacodynamic modeling of the Analgesic Effects of Lumiracoxib, a selective inhibitor of the enzyme COX2 in the Rat
181. Justin Wilkins Occam's razor: Parallel approaches to covariate analysis in modeling covariate effects on the pharmacokinetics of a drug in development
185. James Yates Validation of in vivo Mouse PK Assay by Mixed Effects Modelling: Estimation of between-study variability.
Posters Wednesday Afternoon (group II)
Applications- Anti-infectives
002. Chantal Csajka Population pharmacokinetics of voriconazole in patients with invasive mycoses
006. Oleg Demin Application of pharmacokinetic-pharmacodynamic model to optimize dosing regime of antimicrobial drug Grammidin containing gramicidin S
010. Anne laure Flaugere Population pharmacokinetics of imipenem bone concentrations in pigs
014. Monika Frank Population pharmacokinetic model development and evaluation after nevirapine administration to mothers and newborns
018. Maria Kjellsson Modeling the permeability of Fosfomycin into Abscess Fluid
022. Chantal Le Guellec Population pharmacokinetics of Ceftriaxone in intensive care unit (ICU) adult patients
026. Ana Martin Suarez Population pharmacokinetic model for Ritonavir (RTV) in HIV-infected patients treated with Lopinavir (LPV)/RTV (KaletraTM)
030. France Mentré Parameter estimation of long-term HIV dynamic model in the COPHAR2 - ANRS 111 trial using MONOLIX
034. Michael Neely Voriconazole Population Pharmacokinetics and Pharmacodynamics in Children
038. Saeed Rezaee Population Pharmacokinetics of Vancomycin in Iranian Paediatric Patients
042. Mª Dolores Santos Buelga Population Pharmacokinetics of Lopinavir (KaletraÒ) in HIV-Infected Patients
046. Wynand Smythe Mechanistic pharmacokinetic enzyme model for the characterisation of rifampicin pharmacokinetics in South African pulmonary TB infected adults
050. Ami Fazlin Syed Mohamed Pharmacokinetic/Pharmacodynamic Modeling of Adaptive Resistance of Gentamicin
054. Mita Thapar Population pharmacokinetics of artesunate and dihydroartesunate in adults and children following administration of a fixed dose combination formulation of chlorproguanil-dapsone-artesunate
058. Jan-Stefan van der Walt Effect of rifampicin-based antitubercular therapy and cotrimoxazole on the population pharmacokinetics of stavudine (d4T) in HIV-1 infected patients
062. Jianping Zhang Use of Eltrombopag Exposure-Platelet Response Relationship for Dose Optimization in Patients with Chronic HCV-Infection with and without Interferon
Applications- Coagulation
066. Ekaterina Gibiansky Population Pharmacokinetics of Eltrombopag in Healthy Subjects and Patients with Chronic Idiopathic