Printable version
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 Thrombocytopenic Purpura 070. Anna-Karin Hamberg A longitudinal model describing the relationship between warfarin dose and INR response taking CYP2C9, VKORC1 and age into account 074. Siobhan Hayes Population PK/PD Modeling of Eltrombopag in ITP Patients and Optimization of Response-Guided Dosing 078. Toshihiro Wajima A comprehensive model for the coagulation network in humans
Applications- CVS
082. Anne Chain Not-In-Trial Simulation: Predicting cardiovascular risk from clinical trial data 086. Stefanie Hennig Characterizing time to conversion to sinus rhythm under digoxin and placebo in acute atrial fibrillation 090. Carlos Hoyo-Vadillo Pharmacokinetic Model for Losartan Administered to Young Mexican Healthy Volunteers. 094. Fredrik Jonsson A pharmacokinetic-pharmacodynamic model for ECG pattern changes in dog and monkey 098. Etienne Pigeolet Introducing the renin-angiotensin-aldosterone (RAAS) hypertension platform: an in-silico approach to evaluating efficacy of RAAS modulating drugs on blood-pressure control and end-organ protection 102. Patanjali Ravva Population Pharmacokinetic-Pharmacodynamic Analysis of Weight Loss Efficacy of CP-945,598 in Adult Obese Subjects
Methodology- Design
106. Caroline Bazzoli Prediction of power of test of discrete covariates in population analyses and influence of design: application to gender effect in joint pharmacokinetic models of nucleoside analogs and their active metabolites 110. Massimo Cella Scaling of fixed dose combinations in children 114. Thaddeus Grasela Modeling and Simulation Approach to Pediatric Drug Development 118. Ivelina Gueorguieva Desipramine Population Pharmacokinetic Model and Designing CYP2D6 Drug-Drug Interaction Studies 122. Stefanie Hennig Optimal design for models with semi-parametric distributions 126. Andrew Hooker Autocorrelation reduces sample time clustering in optimal design 130. Frank Kloprogge A model-based approach for dose selection of fixed dose combinations in paediatric indications. 134. Sergei Leonov Estimation of Population Pharmacokinetic Measures and Selection of Sampling Times 138. Rocio Lledo Seeking ethically attractive dose-finding designs for narrow therapeutic index drugs 142. Kayode Ogungbenro Sample Size/Power Calculations for Population Pharmacodynamic Experiments Involving Repeated Count Measurements 146. Patanjali Ravva Enhanced Clinical Trial Design of a Proof-of-Concept Study via Bayesian simulation analyses 150. Marcus Scholz Optimal Design for the improvement of sampling schedules of microdialysis studies. 154. Mike Smith MSToolkit - An R library for simulating and evaluating clinical trial designs and scenarios 158. Shuying Yang Bayesian Adaptive Designs for Phase IIb Dose-ranging Study in Rheumatoid Arthritis (RA)
Posters Thursday Morning (group III)
Applications- CNS
003. Maurice Ahsman Population Pharmacokinetics of Midazolam and Metabolites during Venoarterial Extracorporeal Membrane Oxygenation in Neonates 007. Roberto Bizzotto Multinomial logistic functions in Markov-chain models for modelling sleep architecture after placebo administration 011. Marcus Björnsson A two-compartment effect site model describes the Bispectral Index Score (BIS) after administration of propofol 015. Kristina Bondareva External Validation of the Population Models for Carbamazepine Pharmacokinetics and the Individualizing Carbamazepine Dosage Regimen Procedure 019. Irina Bondareva Population Pharmacokinetics of Carbamazepine and Estimation of Influencing Factors 023. Chao Chen Concentration-Response Modelling of Adjunctive Lamotrigine Extended-Release for Primary Generalised Tonic-Clonic Seizures 027. Chantaratsamon Dansirikul Population pharmacokinetic analysis of pramipexole extended-release formulation in Parkinson's Disease (PD) patients 031. Jeroen Diepstraten Population pharmacokinetics and pharmacodynamics of Propofol in morbidly obese patients 035. Pinky Dua ADAS-Cog Placebo Modelling in Alzheimer's Disease 039. Bart Laurijssens Integrated analysis of Human PET data across multiple brain regions and receptors to make inferences from limited data. 043. Amelie Marsot External validation of pharmacokinetic population model of alfentanil in obese patients. 047. Amir Hooshang Mohammadpour Population pharmacokinetics of carbamazepine in Iranian epileptic and manic patients 051. MYM Peeters The pharmacodynamics of isoflurane in children using Bispectral index and composite auditory evoked potentials 055. Klas Petersson Could prolactin levels be a more informative predictor for clinical effect of D2-receptor antagonists than drug concentrations in the treatment of schizophrenia? 059. Monica Simeoni Prediction of remifentanil metabolic ratio using sparse data collected during non-steady-state infusion with rapidly changing rate 063. Nicolas Simon Population Kinetic Pharmacodynamic and Logistic Regression Analysis of Intravenous Morphine Titration in Immediate Postoperative Period 067. Pyry Välitalo CSF and Plasma Pharmacokinetics of Flurbiprofen in Children 071. Katarina Vucicevic Effect of Valproic Acid Daily Dose on its Clearance in Adult Patients with Epilepsy - Population analysis of TDM data 075. Jonathan Wagg Estimation of cortical amyloid beta turnover rates
Applications- Endocrine
079. Paolo Denti Covariate Selection for the IVGTT Minimal Model of Glucose Disappearance 083. Paolo Denti A NonLinear Mixed-Effects Approach to the Estimation of the Glucose Disposition Index 087. Srividya Neelakantan Exposure-Response Analysis of a DPP-IV Inhibitor, PF-00734200 on HbA1c in Type 2 Diabetic Subjects on Stable Metformin Treatment 091. Sergej Ramusovic A physiologically based pharmacodynamic model of the Renin-Angiotensin-Aldosterone-System 095. Elba Romero Impact of pharmacokinetic information reported as being below limit of quantification on the prediction of important response endpoints. 099. Hanna Silber An integrated model for glucose-insulin regulation to describe oral glucose tolerance test data in healthy volunteers
Methodology- Algorithms
103. Radel Ben-Av Comprehensive Virtual Patient Platform Implemented For Anti-Angiogentic Drugs Development 107. Emmanuelle Comets A bibliographic review of non-parametric methods and their application 111. Vivek Dua Initial Estimates for Parameter Estimation 115. Anne Dubois Extension of the SAEM algorithm and evaluation of Wald and likelihood ratio tests for interaction or bioequivalence studies 119. Charles Ernest Improved parameter estimation and design optimization for In Vitro ligand binding experiments 123. Kevin Feng A New Framework for Combining the 'Bottom-Up' PBPK Paradigm and POP-PK Data Analysis Using Genetic Algorithms and SAEM 127. Bo-Hyung Kim Hierarchical-likelihood approach for nonlinear mixed-effect models 131. Elodie Plan New models for handling correlated underdispersed Likert pain scores 135. Klaas Prins Comparison of a maximum likelihood versus a full bayesian method to jointly model individual with summary level data
Methodology- PBPK
139. Balaji Agoram A Physiologically-Based Mathematical Model to Predict Lung Retention and Inhaled Pharmacokinetics of Therapeutic Candidates 143. Corina Becker Whole-Body Physiologically-Based Pharmacokinetic (WB-PBPK) Modeling of Moxifloxacin (MFX) to Support a Translational Approach in Pediatric Study Design 147. S. Y. Amy Cheung Development of a closed loop whole body (WB) physiologically based pharmacokinetic model (PBPK) of beta-blockers in the rat 151. Brenda de Winter Mechanism-based pharmacokinetic modelling of protein binding of mycophenolic acid and its glucuronide metabolite in renal transplant recipients 155. Gemma Dickinson Prediction of a Metabolic Drug-Drug Interaction in a Virtual Human Population using in vitro Enzyme Kinetic Information 159. Andrea Edginton Parameterization of a physiologically-based pharmacokinetic (PBPK) model for the simulation of ibuprofen pharmacokinetics under exercise and heat stress with validation from clinical data 163. Cecile Gerard Link between cyclosporin exposure in tissues and graft versus host disease in paediatric bone marrow transplantation: analysis by a PBPK model 167. Cecile Gerard Influence of cyclosporin infusion duration on efficacy in paediatric bone marrow transplantation: analysis by a PBPK model 171. Hannah Jones Use of PBPK modelling in drug discovery at Pfizer 175. Klaas Prins Characterization of the population pharmacokinetics of UK-369,003 using a semi-mechanistic model 179. Anastassia Viglinskaya A physiology-based pharmacokinetic model describing the disposition of a novel selective anxiolytic drug afobazole and its metabolites in rats.
Posters Thursday Afternoon (group IV)
Applications- Biologicals/vaccines
004. Leonid Gibiansky Population Pharmacokinetics of AMG 317, a Fully Human Anti-IL-4R±IgG2 Monoclonal Antibody Evaluated in Healthy and Asthmatic Subjects 008. Helene Karcher Harnessing clinical knowledge on ligand-targeting drug to develop a new compound targeting the associated receptor : an example of model-based biologics design in pre-clinical development 012. Wojciech Krzyzanski Receptor Mediated Disposition PK/PD Model of Filgrastim in Healthy Adults following Intravenous and Subcutaneous Administrations. 016. Brigitte Lacroix Comparison between the Exposure-Response Modeling of the ACR20 and ACR50 Scores in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol. 020. Philip Lowe Omalizumab (Xolair) may normalise IgE production rate in patients with moderate-to-severe atopic asthma 024. Philip Lowe Pharmacokinetics of canakinumab and pharmacodynamics of IL-1ß binding in patients with cryopyrin associated periodic fever syndromes 028. Philip Lowe On the ability to predict free ligand suppression when free ligand assays are not available or impossible 032. Philip Lowe Relationship between omalizumab pharmacokinetics and IgE pharmacodynamics in adult and pediatric patients with moderate to severe persistent allergic (IgE-mediated) asthma 036. Scott Marshall Population Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis of the Effect of Tanezumab on Overall Daily Pain Score Data in Adults with Moderate-to-Severe Pain due to Osteoarthritis of the Knee 040. Etienne Pigeolet Artefactual inflation of pharmacokinetic difference between two Granulocyte Colony Stimulating Factor (G-CSF) drug products by non compartmental analysis. 044. Elisabeth Rouits Target-Mediated Drug Disposition model to describe non-linear kinetics of a Monoclonal Antibody
Applications- Oncology
048. Lorea Bueno Semi-Mechanistic Modelling of the Tumour Growth Inhibitory Effects of a New Anti-angiogenic Drug. 052. Damien Cronier A fully integrated PK/IVTI/IVE model in mouse to help design the FHD trial for a cell cycle inhibitor X 056. Maxime Fontanillles Modelization of bevacizumab effect on tumour perfusion assessed by Dynamic Contrast Enhanced Ultrasonography 060. Ludivine Fronton Population model of Human Chorionic Gonadotropin to predict resistance in low risk gestational trophoblastic neoplasia patients 064. Maria Garrido Pharmacokinetics and antitumor efficacy characterization of cisplatin-loaded PLGA nanoparticles in tumor-bearing mice. 068. Marianne Guery Data mining analysis of survival data in cancer of pancreas : first exploratory step for identification and validation of explicative variables 072. Emma Hansson Pharmacokinetic-Pharmacodynamic Modeling of the Angiogenic Factors VEGF, sVEGFR-2, sVEGFR-3 and sKIT following Sunitinib Treatment in GIST 076. Georg Hempel Physiologically-Based Pharmacokinetic (PBPK) Model for High- and Low Dose Etoposide: From Adults to Children 080. Åsa Johansson Pharmacokinetics of high-dose methotrexate in adults and children 084. Andreas Lindauer Pharmacokinetic/Pharmacodynamic Modeling of Sunitinib in Healthy Volunteers 088. Laurent Nguyen Validation of a neutropenia PK/PD model built from intravenous vinflunine and its application to design phase I trials with oral vinflunine 092. Celine Pitou Modelling of PK/Efficacy/Toxicity in rats to help design a First Human Dose for a cell cycle inhibitor X 096. Christian Pobel Time to event models of survival in cancer of pancreas : confirmation of explanatory variables pre-selected by bootstrap analysis. 100. Angelica Quartino A semi-mechanistic myelosuppression model of docetaxel treatment in liver impaired patients 104. Alexandre Sostelly Simultaneous modelling of PSA production in Prostatic Benign Hyperplasia (PBH) and prostatic adenocarcinoma patients treated by prostate surgery 108. Mirjam Trame Population Pharmacokinetics of Dimethylacetamide in Children During Once-daily and Standard IV Busulfan Administration 112. Johan Wallin Model Based Neutrophil Guided Dose Adaptation in Chemotherapy 116. Xiaofeng Wang Population PK modeling and simulation to select a dosing schedule in Phase II trials for a novel TKI agent with time-dependent and nonlinear PK
Methodology- Model evaluation
120. Martin Bergstrand Visual Predictive Checks for Censored and Categorical data 124. Anton Korobeynikov Comparison of Parameter Estimates for One Special Model of Survival Curves for Sample with Interval Censoring 128. Elke Krekels Evaluation of two models for morphine pharmacokinetics in neonates and infants. 132. Sergei Kulikov New parametric model for survival fitting 136. Bojan Lalovic Impact of Dosing Regimens on Dropout Across Pregabalin Trials in the Treatment of Generalized Anxiety Disorder: Model Refinements and External Validation 140. Marta Neve Assessment of NONMEM and WinBUGS performances when estimating power and sigmoid Emax models 144. Richard Nixon Using short-term evidence to predict six-month outcomes in clinical trials of signs and symptoms in rheumatoid arthritis 148. Elodie Plan Eleven ordered categories data: which modelling options? 152. Alberto Russu Dose escalation studies: a comparison among Bayesian models
|