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The full program and all abstracts can be downloaded as a single Word document here.
Software demonstrations
Bayer Technology Services Insightful Mango Solutions NonLinear Mixed Effects Consortium SimCYP 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 Therapies Rogier 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
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