Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (75)

IV-01Brigitte Lacroix

A quantitative framework integrating exposure, efficacy, receptor occupancy and tolerability to propose evidence-based dose regimens for padsevonil

Thursday 15:10-16:40

IV-02Shankar Lanke

Population Pharmacokinetic Analyses of Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease

Thursday 15:10-16:40

IV-03

Population pharmacokinetics of Rimeporide in healthy volunteers and children suffering from Duchenne Muscular Dystrophy (DMD)

Thursday 15:10-16:40

IV-05Robert Leary

Automatic framework for bioequivalence studies from In Vitro test to In Vivo study design

Thursday 15:10-16:40

IV-06Woo Yul Lee

A population pharmacodynamic model of combination antidepressant therapy in depression

Thursday 15:10-16:40

IV-07Quentin Leirens

Clinical Trial Simulation of a Phase I Paediatric Oncology Study using Simulo

Thursday 15:10-16:40

IV-08Jennifer Leohr

A Categorical Model of Sweet/Fat Preference Taste in Lean, Obese and Very Obese Subjects

Thursday 15:10-16:40

IV-09Giulia Lestini

Two-step modelling approach of time to event and cognitive decline to inform Alzheimer’s disease prevention trials

Thursday 15:10-16:40

IV-10Leticia Arrington

A Model Based Meta-Analysis (MBMA) to support development of medicines for treatment of DPN, PHN and Fibromyalgia.

Thursday 15:10-16:40

IV-11Hyeong-Seok Lim

Pharmacokinetic and Pharmacodynamic Evaluation of Intravenous Levetiracetam in Children with Epilepsy

Thursday 15:10-16:40

IV-12Sihang Liu

Population PK/PD analysis of ropinirole as a potential treatment for hyperprolactinemia

Thursday 15:10-16:40

IV-13Rasmus Jansson Löfmark

Pharmacokinetic population modelling of a GLP1 beta cell targeting oligonucleotide

Thursday 15:10-16:40

IV-14Philip Lowe

Ligelizumab Paediatric Investigation Plan: exposure-response analysis in adult chronic spontaneous urticaria with simulation-based design of adolescent dose-finding

Thursday 15:10-16:40

IV-15Qiang Lu

Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma

Thursday 15:10-16:40

IV-16Rubin Lubomirov

Population pharmacokinetic-based targeted exome sequencing (PopPK-TES) approach to assess the impact of genetic variants on pharmacokinetics of lurbinectedin in patients with advanced cancer

Thursday 15:10-16:40

IV-17Sreenath M Krishnan

Accuracy in the estimation of the hazard in simultaneous and sequential estimation approaches of tumor size and overall survival (OS) modeling

Thursday 15:10-16:40

IV-18Lei Ma

Efpeglenatide dose selection for a phase 3 study in type 2 diabetes mellitus (T2DM) patients: pharmacokinetics and pharmacodynamics (PK/PD) modeling, network meta-analysis and clinical trial simulation

Thursday 15:10-16:40

IV-19Matthias Machacek

A Systems Pharmacology model of peripheral serotonin production proposing two different synthesis compartments with markedly different release rates into blood

Thursday 15:10-16:40

IV-20Paolo Magni

Evaluation of software tools for Bayesian estimation on population models: an update based on current software versions

Thursday 15:10-16:40

IV-21Corinna Maier

Improving model-based predictions of neutropenia using sequential data assimilation

Thursday 15:10-16:40

IV-22Victor Mangas-Sanjuan

Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles

Thursday 15:10-16:40

IV-23Jialin Mao

PBPK modelling of drug-drug interactions driven by moderate CYP3A inducers

Thursday 15:10-16:40

IV-24Anita Mathias

Joint population pharmacokinetic modelling of sofosbuvir and its metabolites (GS-566500, GS-331007) in Hepatitis C Virus (HCV)-infected adolescents receiving sofosbuvir or ledipasvir/sofosbuvir

Thursday 15:10-16:40

IV-25Tomomi Matsuura

Clinical validation of a quantitative systems pharmacology (QSP) model for nerve-growth-factor (NGF) therapies

Thursday 15:10-16:40

IV-26Hannah Mayer

A novel approach to estimate ontogenies for PBPK applications – From literature data to simulations

Thursday 15:10-16:40

IV-27Christophe Meille

PKPD modeling of preclinical anti-tumor activity translates to first-in-human phase I study of MDM2 inhibitor HDM201

Thursday 15:10-16:40

IV-28Nicola Melillo

Variance based Global Sensitivity Analysis of a Physiological Absorption model for compounds in different BCS classes

Thursday 15:10-16:40

IV-29Johanna Melin

Dapagliflozin pharmacokinetics is similar in adults with type 1 and type 2 diabetes mellitus

Thursday 15:10-16:40

IV-30Matilde Merino-Sanjuán

Evaluation of the impact of undernourishment on the intestinal absorption of gefitinib in rats.

Thursday 15:10-16:40

IV-31Jonathan Mochel

Modeling Primary Tumor Growth in a Xenograft Mouse Model of Non-Small Cell Lung Cancer Treated With Pemetrexed-Cisplatin and Bevacizumab

Thursday 15:10-16:40

IV-32Claudio Monteiro Sousa

An in silico HBV model predicts viral response to the oral non-steroidal carboxylic acid FXR agonist EYP001a.

Thursday 15:10-16:40

IV-33Denise Morris

Population Pharmacokinetic Modeling of Fremanezumab in Support of Phase 3 Development for Patients with Migraine

Thursday 15:10-16:40

IV-34Ricardo Nalda-Molina

Population Pharmacokinetics of Hyperthermic Intraoperative Peritoneal Oxaliplatin in Wistar Rats

Thursday 15:10-16:40

IV-35Antonina Nikitich

Immune Response Template for Quantitative Systems Pharmacology Modeling: Description of Co-inhibitory and Co-stimulatory Receptors Interaction

Thursday 15:10-16:40

IV-36Asbjørn Nøhr-Nielsen

A review of fixed-dose combination approvals in the EU based on European public assessment reports (EPARs)

Thursday 15:10-16:40

IV-37Patrick Nolain

PopkinR: a suite of Shiny applications focused on the pharmacometrics workflow

Thursday 15:10-16:40

IV-38Rikard Nordgren

Faster methods for case deletion diagnostics: dOFV and linearized dOFV

Thursday 15:10-16:40

IV-39Ana Novakovic

Simulation based assessment of flat dose regimen of an anti-PDL1 antibody: Case study of avelumab

Thursday 15:10-16:40

IV-40Eric Novik

Stan: an open source probabilistic programming language for high-performance statistical computing

Thursday 15:10-16:40

IV-41Katharina Och

A pharmacokinetic/pharmacodynamic model of cyclosporine A and its nephrotoxicity in patients after hematopoietic stem cell transplantation

Thursday 15:10-16:40

IV-42Chika Ogami

Population pharmacokinetics of unbound daptomycin in hospital patients with Gram-positive infections

Thursday 15:10-16:40

IV-43Boram Ohk

Population pharmacokinetics of sumatriptan in healthy korean subjects : sex differences

Thursday 15:10-16:40

IV-44Andrés Olivares-Morales

Switching from immediate release to modified release can have an impact on intestinal drug-drug interactions: A PBPK simulation study using oxybutynin as a case example

Thursday 15:10-16:40

IV-45Erik Olofsen

The definition and interpretation of utility functions

Thursday 15:10-16:40

IV-46Sean Oosterholt

Implications of a model-based dosing algorithm for tacrolimus in paediatric kidney transplantation

Thursday 15:10-16:40

IV-47Taniya Paiboonvong

Population Pharmacokinetics of Sitafloxacin in Thai Critically Ill Patients with Pneumonia

Thursday 15:10-16:40

IV-48Kwan Cheol Pak

Physiologically based pharmacokinetic modeling of Herceptin and human pharmacokinetic prediction

Thursday 15:10-16:40

IV-49Semra Palic

Exploring dose-dependent pharmacokinetics of miltefosine in pediatric visceral leishmaniasis patients from East Africa

Thursday 15:10-16:40

IV-50- -

Efficacy and toxicity of intravenous salbutamol in children with acute severe asthma: a prospective clinical PKPD study

Thursday 15:10-16:40

IV-51Alice Panchaud

Prediction of escitalopram exposure in infants through breastfeeding by modeling and simulation

Thursday 15:10-16:40

IV-52Navarat Panjasawatwong

Population pharmacokinetics of rifampicin in Vietnamese Children with Tuberculous Meningitis

Thursday 15:10-16:40

IV-53Christophe Passot

Therapeutic drug monitoring of eculizumab in atypical hemolytic uremic syndrome

Thursday 15:10-16:40

IV-54

Using real world data to assess SGLT2 Inhibitor cardiovascular benefit and impacts of patient population characteristics

Thursday 15:10-16:40

IV-55Henning Schmidt

Reproducible submission-ready Word reports based on open source tools

Thursday 15:10-16:40

IV-56Violeta Balbas-Martinez

Physiologically-Based Pharmacokinetic model for Ciprofloxacin in healthy children and approximation to children with complicated Urinary Tract Infection

Thursday 15:10-16:40

IV-57Cesar Pichardo

QSP Modelling of Neurodegenerative Chronic Diseases and Brain Biomarkers: Adding the Effect of Ageing on Brain Volume

Thursday 15:10-16:40

IV-58Philippe Pierrillas

PKPD modelling of EYP001a (a novel FXR agonist) in healthy volunteers and Hepatitis B patients

Thursday 15:10-16:40

IV-59Etienne Pigeolet

Modeling of amyloid accumulation in subjects at risk of Alzheimer’s disease under BACE inhibition treatment.

Thursday 15:10-16:40

IV-60Nikhil Pillai

Estimating parameters of chaotic systems: chaos synchronization combined with Nelder-Mead search

Thursday 15:10-16:40

IV-61Eduard Schmulenson

A physiologically-based pharmacokinetic modeling approach to assess the impact of chronic kidney disease

Thursday 15:10-16:40

IV-62Teun Post

An HCV nucleoside inhibitor MK-3682 minimal PBPK-PD model for application in hypothesis generation regarding metabolic pathways and perturbations under various conditions

Thursday 15:10-16:40

IV-63Manuel Prado-Velasco

New approach based on physiological modelling to compute the bioavailability using the PhysPK biosimulation system

Thursday 15:10-16:40

IV-64Jens Przybilla

Epigenetic modelling of DNA demethylation therapy in Acute Myeloid Leukemia

Thursday 15:10-16:40

IV-65Alicja Puszkiel

Quantitative evaluation of the impact of CYP2D6 genetic polymorphisms on pharmacokinetics of tamoxifen and its metabolites in breast cancer patients

Thursday 15:10-16:40

IV-66Luis Quintairos Domenech

Pharmacodynamic modelling of biomarkers in kidney transplantation: a transformed binary data population approach

Thursday 15:10-16:40

IV-67Hanne Refsgaard

Steps Towards a Robust Generic Method for Deconvolution Directly on Pharmacokinetic Profiles

Thursday 15:10-16:40

IV-68Theo Reijmers

Population PK Modelling of Treosulfan in Paediatric Allogeneic Transplant Patients

Thursday 15:10-16:40

IV-69François Riglet

Multiple response modelling of mycophenolic acid pharmacokinetics in adult patients with transplanted kidneys by population approach

Thursday 15:10-16:40

IV-70Christer Rimmler

Evaluating New Dosing Strategies for the Use of Cefuroxime in Perioperative Antibiotic Prophylaxis using PBPK

Thursday 15:10-16:40

IV-71Christelle Rodrigues

A population pharmacokinetic model taking into account protein binding for the sustained-release granule formulation of valproic acid in children with epilepsy

Thursday 15:10-16:40

IV-72Leire Ruiz Cerdá

External validation of Systems Pharmacology Models of the Coagulation Network with published data

Thursday 15:10-16:40

IV-73

Treatment allocation adaptive randomization methods in clinical trials with few individuals may influence model parameter estimation

Thursday 15:10-16:40

IV-74Oliver Sander

Detecting and Analyzing 5x Sit-to-Stand Tests from Accelerometer Data

Thursday 15:10-16:40

IV-75Stein Schalkwijk

Exploring Standard and Alternative Darunavir/Ritonavir Dosing Regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modeling

Thursday 15:10-16:40

IV-76Stephan Schaller

Towards Predictions of Clinical Trial Outcomes: Combining PBPK and QSP within a Translational Diabetes Disease Platform

Thursday 15:10-16:40