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Software demonstrations: Commercial
Pharsight: Phoenix platform, WinNonlin, Trial Simulator, WinNonlin AutoPilot, and PKS (a PK/PD data repository) ICON Development Solutions: Hands-On Demonstration of PDx-Pop® v3.0; Tools for Expediting Population Analysis Simcyp: Simcyp Simulator - a comprehensive platform and database for mechanistic modelling and simulation of oral drug absorption, tissue distribution, metabolism and elimination in healthy and disease populations using in vitro knowledge GastroPlus: GastroPlus Mango Solutions: Mango Solutions PK-Sim: Hands-On Demonstrations of the Physiology-Based Pharmacokinetic Software, PK-Sim®
Software demonstrations: Non-commercial
Carlos Hoyo-Vadillo Four Programs for Writing and Running Nonmem Scripts Roger Jelliffe The USC*PACK software for nonparametric adaptive grid (NPAG) population PK/PD modeling, and the MM-USCPACK clinical software for individualized drug regimens Saik Urien RfN, R for Nonmem: A graphical interface for Nonmem outputs Rich Haney Open Statistical Services Andrew Hooker PopED Andrew Hooker Xpose and Perl speaks NONMEM(PsN) Marc Lavielle Analysing population PK/PD data with MONOLIX 2.4 and writing complex models with MLXTRAN
Posters Wednesday Morning (group I)
Applications- Other topics
Corina Becker Whole-Body Physiologically-based Pharmacokinetic (WB-PBPK) Population Modelling to Simulate the Influence of Weight and Age on the Pharmacokinetics (PK) of a combined Oral Contraceptive Containing Drospirenone (DRSP) and Ethinylestradiol (EE) Misba Beerahee Clinical Trial Simulation to Estimate the Sample Size for Investigation of the Impact of a Drug A on the Pharmacokinetics of Methotrexate, a common co-medication used in Rheumatoid Arthritis (RA) Pascal Chanu Decisive support of Modeling & Simulation for getting drug approval in the context of safety concern on the drug class Chao Chen Population PK/PD modelling of functional receptor occupancy in a first-time-in human study Emmanuelle Comets Modelling is seldom used to describe pharmacokinetics in phase I clinical trials Mike Dunlavey Simplified programming of population model user interfaces Yumi Emoto Evaluation of Population PK/PD for Osteoporosis during a Vitamin D3 (1,25(OH)2D3) Derivative Therapy Samuel Fanta Population Pharmacokinetics of Cyclosporine in Paediatric Renal Transplant Recipients Dymphy Huntjens Receptor-mediated pharmacokinetic modeling of a novel anti-epileptic drug in healthy volunteers Daniel Jonker The pharmacokinetics of the once-daily human glucagon-like peptide-1 analogue, liraglutide, across 5 trials in healthy subjects and type 2 diabetics after single and multiple dosing Catherijne Knibbe Predictive Value of Allometric Scaling for Estimation of Propofol Clearance in Neonates, Infants and Adolescents Elke Krekels Development AND External validation of a model for Glucuronidation in children below 3 years of age using morphine as a model drug; towards a novel dosing paradigm. Glynn Morrish Using Body Composition Metrics to Predict Exposure Between Japanese and Caucasian Populations Flora Musuamba-Tshinanu Limited sampling formulas and bayesian estimation for mycophenolic acid 12 hours Area Under the concentration-time Curve prediction in Stable renal transplant recipients co-medicated with cyclosporine or sirolimus Rogier Press Optimizing Calcineurin Inhibitor Exposure In De Novo Kidney Transplant Recipients Jean Smeets A Mechanism-based Pharmacokinetic Model Describing the Interaction Between Sugammadex and Rocuronium in Patients with Normal and Impaired Renal Function Tamara van Steeg Assessment of the use of complex baseline models in preclinical safety screening: Application of the van der Pol oscillator model to describe heart rate effects in rats Johan Wallin Population pharmacokinetics of tacrolimus in paediatric bone marrow transplant recipients Susan Willavize Dose Selection for Combination Drug Products Susan Willavize Using M&S to Shorten the Repeating Cycle of the Early Drug Development Process: A Case Study
Methodology- Other topics
Paul Baverel Covariate Model Building Method for Nonparametric Estimation Method in NONMEM VI: Application to Simulated Data Martin Boucher A Bayesian Meta-Analysis of Longitudinal Data in Placebo Controlled Studies with Naproxen Marylore Chenel How to show average bioequivalence of concentrations in a test sample with a reference population pharmacokinetic model? Cian Costello A Time Scaling Approach to Develop an In Vitro-In Vivo Correlation (IVIVC) Model Using a Convolution-Based Technique Ekaterina Gibiansky Indirect Response Models with Positive Feedback: Equations, Properties, and Possible Applications Andreas Velsing Groth Alternative parameterisations of saturable (Emax) models allowing for nesting of non-saturable models Emilie Henin Patient compliance estimated from pharmacokinetic sample: application to Imatinib Matt Hutmacher Implications for animal-human scaling of the parallel elimination profile PK model Ibrahim Ince Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling Ron Keizer A simple infrastructure and graphical user interface (GUI) for distributed NONMEM analysis on standard network environments Charlotte Kloft Launch of the Graduate Research Training (GRT) Program 'Pharmacometrics & Computational Disease Modelling' in Germany Ricardo Nalda-Molina Pharmacokinetic and Pharmacodynamic Model for Drug Induced Transient Transaminitis Carmen Navarro Estimating the complete AUC and its standard error in sparse sampling designs. Klas Petersson Transforming parts of a differential equations system to difference equations as a method for run-time savings in NONMEM VI Angelica Quartino Comparison Between using Continuous and Categorical Toxicity Data for Estimation with a Model for Continuous Data Radojka Savic A novel bootstrap method for obtaining uncertainty measurement around the nonparametric distribution Nabil Semmar Independent-model diagnostics for a priori identification and interpretation of outliers from a full pharmacokinetic database: correspondence analysis, Mahalanobis distance and Andrews curves Steven Xu Exposure-Response Analysis of Adverse Events in Clinical Trials Using Zero-Inflated Poisson Modeling With NONMEM®.
Posters Wednesday Afternoon (group II)
Applications- Anti-infectives
Caroline Bazzoli Population pharmacokinetics of AZT and its active metabolite AZT-TP in HIV patients: joint modelling and design optimisation Helena Colom Population pharmacokinetics of Ganciclovir following Valganciclovir in solid organ transplant recipients infected by cytomegalovirus Anne Dubois Population analysis of plasma and intracellular pharmacokinetics of indinavir in HIV-1 infected patients with a stable antiretroviral therapy Monika Frank Nevirapine - Population pharmacokinetic model building and simulation for mothers and newborns Maria Jose García Population Pharmacokinetics of Efavirenz in HIV-infected patients: Pharmacogenetic analysis Sylvain Goutelle A Population Pharmacokinetic Study of Plasma and Intrapulmonary Concentrations of Rifampin Sylvain Goutelle Influence of Rifampin Pharmacokinetic Variability on Antibacterial Effect and Prevention of Resistance in Pulmonary Tuberculosis: a Simulation Study Flora Musuamba-Tshinanu Simultaneous Therapeutic Drug Monitoring Of Amikacin And Beta-Lactams In Intensive Care Unit Patients With Severe Sepsis Or Septic Shock Without Beta-Lactam Serum Concentration Monitoring Partha Nandy Relationship Between a PK/PD Parameter and Therapeutic Response of Ceftobiprole in Patients with Complicate Skin and Skin Structure Infection Michael Neely Population Kinetics and Dynamics of Lopinavir in HIV-Infected Children Elisabet Nielsen Developmental Pharmacokinetics of Gentamicin in Preterm and Term Neonates: Modelling and Simulation Based on Data from a Prospective Study Daniel Röshammar Population Pharmacokinetics of Efavirenz and MDR-1, CY2B6, and CYP3A5 Polymorphisms Catherine Mary Turner Sherwin Simulation and development of a netilmicin extended dosing regimen for extremely premature neonates. Nicolas Simon Population Pharmacokinetics of Atazanavir in HIV-infected Patients Joel Tarning Population pharmacokinetics of lumefantrine in pregnant women treated with co-artemether for uncomplicated falciparum malaria Jan-Stefan van der Walt Population pharmacokinetic models for lamivudine and nevirapine to assess drug concentrations obtained during therapeutic drug monitoring Wei Zhao Population Pharmacokinetics of Ganciclovir Following Oral Administration of its Prodrug Valganciclovir in Pediatric Renal Transplant Patients
Applications- Coagulation
Xavier Delavenne Assessment of pharmacokinetic variability of fondaparinux in 809 patients treated after major orthopedic surgery: the POP-A-RIX study
Methodology- Design
Massimo Cella Randomisation to exposure in early paediatric trials: an analysis on the influence of the dose on the heterogeneity in the response to abacavir. Marylore Chenel Optimal design of QTc interval measurements for circadian rhythm determination Marion Dehez Optimal window design of blood pressure time measurements in hypertensive dippers and non-dippers using ABPM: Application of the compound D-optimality approach. Phey Yen Han Informative Study Designs to Identify True Parameter-Covariate Relationships Joakim Nyberg Application of Optimal Design for Disease Progression Studies Tracy Higgins Simulation and Design Considerations for Noninferiority Trials in Phase II Hyung Ki Kim The Effect of Study Design on Pharmacokinetics in Patients with Impaired Renal Function Rocio Lledo Impact of study design for characterising PKPD covariance and nonlinearity in exposure-dichotomous response relationships Rocio Lledo Randomised dose controlled trials or concentration controlled trials when learning about drugs with narrow therapeutic index? Mark Lovern Development of a Bayesian Adaptive Sampling Time strategy for PK studies with constrained number of samples to ensure accurate estimates. Mark Lovern Leveraging complicated PK/PD models for the development of a Bayesian adaptive Dose-ranging design. Guy Meno-Tetang The Use of Clinical Trial Simulation to investigate Bias in Crossover Studies with a Short Washout Period and no Placebo Arm: Application to Neuropathic Pain Joakim Nyberg Dose and sample time optimization of drug candidate screening experiments Kayode Ogungbenro An Effective approach for Obtaining Optimal Sampling Windows for Population Pharmacokinetic Experiments Italo Poggesi Evaluation of direct population PKPD models for truncated concentration-response curves Alberto Russu Dose escalation studies: a comparison between NONMEM and a novel Bayesian tool David Salinger Mean Squared Error as Criterion for Sampling Schedule Optimization for Individual Dose Targeting in IV Busulfan Hanna Silber Improvement of the intravenous glucose tolerance test using optimal experimental design. Stefano Zamuner Adaptive Optimal Design in PET Occupancy Studies
Posters Thursday Morning (group III)
Methodology- Algorithms
Julie Antic Some Stochastic Algorithms For The Smooth Non Parametric (SNP) Estimator Julie Bertrand Properties of different tests to detect the effect of a genetic covariate on pharmacokinetic parameters using the SAEM algorithm for several designs Vivek Dua Automatic Selection of Optimal Configuration of Artificial Neural Networks Clare Gaynor A Differential Equations Approach to In Vitro - In Vivo Correlation Modelling in NONMEM Leonid Gibiansky Parameter Estimates of Population Models: Comparison of Nonmem Versions and Estimation Methods Leonid Gibiansky Approximations of the Target-Mediated Disposition Model and Identifiability of Model Parameters Leonid Gibiansky Application of Identifiability Analysis Algorithm to Population PK of the Drug with Target-Mediated Disposition Søren Klim Linear Mixed Effects models based on Stochastic Differential Equations in R François Mercier Simulation and evaluation of bivariate Beta distribution for interval response variables Benjamin Ribba Monolix benefits from external modules to manage complex ODE: Illustration with a population analysis of Irinotecan and its metabolites. Rich Haney Accelerating the Rate of Adoption of New Pharmacometrics Platforms Using Formal Tools for Model Interconversion
Applications- Biologicals/vaccines
Daren Austin Use of mechanistic models to estimate target antigen load for monoclonal antibodies Brigitte Lacroix Exposure-response analysis of certolizumab pegol in Crohn's disease population Brigitte Lacroix Exposure-Response Modeling of the ACR20 Score in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol Micha Levi Relationship Between Serum Concentration of the Interleukin-6 Receptor Inhibitor, Tocilizumab (TCZ), and Disease Activity Score (DAS28) in Patients with Rheumatoid Arthritis Etienne Pigeolet Granulocyte Colony Stimulating Factor Pharmacokinetics After Single and Repeated Administration of Several Doses. David Ternant Development of anti-infliximab antibodies increases infliximab clearance in inflammatory bowel diseases Justin Wilkins Bioequivalence, bootstrapping and case-deletion diagnostics in a biologic: a model-based analysis of the effect of formulation differences in a monoclonal antibody
Applications- CNS
Aliénor Bergès Using VT (total volume of distribution from PET) in estimating the PK-Receptor Occupancy relationship in the absence of reference regions Chao Chen Population modeling of the relationship between ropinirole systemic exposure and efficacy in Parkinson's disease Rik de Greef Modeling and Simulation to Integrate Efficacy and Safety Data Following Full Development: a Case Study in Schizophrenia and Bipolar Disorder Geraldine Ferron PK and PK/PD modeling of CB1 blocker antagonism of THC induced CNS and Heart Rate effect Sophie Gisbert Analysing Raw Count data from an In Vitro Target Occupancy Assay to Select Doses for Human Safety/Tolerability Trial Dymphy Huntjens PK/PD modeling of apomorphine-induced behaviour in macaques Brigitte Lacroix Population Pharmacokinetics of Brivaracetam in Patients with Partial Epilepsy Bart Laurijssens Model-Based Analysis of a Longitudinal Binary Response as the Primary Analysis for a Phase II Study in Migraine Prophylaxis. Otilia Lillin-de Vries A population analysis on the effects of the CYP2D6 deficiency on pharmacokinetics and exposure of esmirtazapine in healthy volunteers. Igor Locatelli Population Pharmacokinetics of Risperidone in Patients with Acute Schizophrenia Guangli Ma Pool Model versus Agonist-Antagonist Interaction Model for the Remoxipride Effect on Prolactin Sarah McLeay Scaling propofol doses for the obese: is lean body weight the answer? Raymond Miller Exposure-Response Analysis of Longitudinal Adverse Event Data. Gianluca Nucci A sparse sample PK/PKPD approach to estimate the time course of antipsychotic-induced D2 occupancy Elba Romero Extended Link Model to Describe the Impact of Chronic Antiepileptic Therapy on the Effects of Neuromuscular Blocking Agents. Monica Simeoni Modelling beta amyloid system: sensitivity analysis at steady state and in dynamic conditions. Armel Stockis Levetiracetam exposure-response analysis in children with partial onset seizures Katarina Vucicevic Estimation of Relative Bioavailability of Controlled-Release Carbamazepine Tablets Based on Routine TDM Data Stefano Zamuner Mixed Effects Markov Models for Modelling Sleep in Insomniac Patients Treated with Placebo in a 28 Days Trial: Emphasis on the Break Points Selection
Posters Thursday Afternoon (group IV)
Applications- CVS
Massimiliano Germani Nonparametric Modeling and Population Approach to the Individualized Heart Rate Correction of the QT Interval Ihab Girgis Bayesian Modeling of QT Measurements: Focus on Baseline QTc Carlos Hoyo-Vadillo Pharmacokinetics model for Nifedipine administered to Healthy Volunteers. Kevin Krudys Bridging Cardiovascular Risk from Clinical Trials to Real Life Population
Applications- Endocrine
Paolo Denti Comparison of Different Population Analysis Approaches to the IVGTT Glucose Minimal Model Silke Dittberner Target mediated drug disposition model for the DPP-4 inhibitor BI1356 (proposed trade name ONDERO): Is the structure identifiable? Silke Dittberner BI 1356 (proposed trade name ONDERO) pharmacokinetics and DPP-4 inhibition: Development of a target mediated PKPD model in type 2 diabetic patients Maria Garrido Simultaneous population pharmacodynamic modelling of the growth hormone and insulin-like growth factor-I effects after deep subcutaneous administration of Lanreotide Autogel® in acromegalic patients. Application of Nonparametric estimation method in NONME Cyrus Ghobadi Pharmacokinetics of oral single-dose clomiphene citrate (CC) in polycystic ovary patient with anovulatory infertility Tae Han Alteration of glucose and insulin regulatory networks for the treatment of type 2 diabetes mellitus Nick Holford Delayed response to hypoglycaemic agents and effect on progression of type 2 diabetes Petra Jauslin Identification of the Mechanism of Action of a Glucokinase Activator from OGTT Data in Type 2 Diabetics Using an Integrated Glucose-Insulin Model Teun Post Disease System for osteoporosis: relating bone mineral density with measures of bone formation and resorption based on bone biology Rujia Xie Model-Based Drug Development (MBDD) of Pegylated Growth Hormone (PEG-hGH) in the Treatment of Adult Growth Hormone Deficient (AGHD) Rujia Xie Relationship between the Dose of Recombinant Human Growth Hormone (rhGH) and Insulin Growth Factor-1 (IGF-1) in Adult Patients with Growth Hormone Deficiency (AGHD)
Applications- Oncology
René Bruno Modeling and simulation to assess the use of change in tumor size as primary endpoint in Phase II studies in oncology Antonin Schmitt External validation of a model based on cystatin C to predict carboplatin clearance Francesca del Bene Evaluating the Influence of Different Sources of Variability in the PK/PD Tumor Growth Inhibition (TGI) Model Nicolas Frances Modeling of longitudinal tumor size data in clinical oncology studies of drugs in combination Lena Friberg Scaling the Time-Course of Myelosuppression from Rats to Patients with a Semi-Physiological Model Maria Garrido Biopharmaceutic and pharmacodynamic characterization of the in vitro anti-proliferative effect of new delivery systems of Cisplatin Massimiliano Germani Evaluating the Influence of Different Sources of Variability in the PK/PD Tumor Growth Inhibition (TGI) Model Emma Hansson The Shape of the Myelosuppression Time-course is Related to the Probability of Developing Neutropenic Fever in Patients with Docetaxel-induced Grade IV Neutropenia Emma Hansson Comparison of Inter-Occasion and Inter-Individual Variability in Chemotherapy- Induced Myelosuppression Ron Keizer Population PK-PD modeling of E7820 and ±2-integrin expression on platelets in patients with solid tumors and lymphomas Stijn Koolen Population pharmacokinetics of intravenously and orally administered docetaxel with or without co-administration of ritonavir in patients with advanced cancer Katharina Küster Matuzumab - Evaluation of the Population Pharmacokinetic Model and Analyses of the Covariate Impact on the Pharmacokinetic Profile Andreas Lindauer Population Pharmacokinetics of High-dose Carboplatin Elena Soto A semi-mechanistic population pharmacokinetic/pharmacodynamic model for neutropenia following therapy with the new PLK-1 inhibitor BI 2536 and its application in clinical development Kellie Turner Reduced Folate Carrier Single Nucleotide Polymorphism Associated with Methotrexate Clearance in Breast Cancer Patients
Methodology- Model evaluation
Robert Bies A comparison of a genetic algorithm based automated search algorithm to standard stepwise approach for population pharmacokinetics using NONMEM. Carlos Fernandez-Teruel Simulations of bioequivalence trials using physiological-pharmacokinetic in single dose and steady state scenarios. Which scenarios are refusable? Laura Iavarone A Population PK model to evaluate variability in oral absorption using gamma scintigraphy Robert Leary Nonparametric Analogs to POSTHOC Estimates for Exploratory Data Analysis Gianluca Nucci Modelling and Simulation of Ketoconazole inhibition when co-administration time is not sufficient: role of CYP3A function recovery
Methodology- PBPK
Viera Lukacova PBPK modeling of metoprolol and its metabolites Italo Poggesi Evaluation of a basic PBPK model in preclinical species for which tissue compositions are unknown
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