Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (89)

II-01Åsa Kragh

Population pharmacokinetic analysis of PT010, an inhaled triple fixed-dose combination product, in patients with chronic obstructive pulmonary disease

Wednesday 15:10-16:40

II-02Markus Krauß

Mice with human livers improve First-in-Human prediction of pharmacokinetics

Wednesday 15:10-16:40

II-03Rukmini Kumar

Quantitative Systems Pharmacology (QSP) tools to aid in model development and communication: Vantage QSP Modeling Tools (VQM-Tools)

Wednesday 15:10-16:40

II-04Hanna Kunina

Diabetes progression modelling of competing risks of long-term complications and mortality using Swedish registry data

Wednesday 15:10-16:40

II-05Sofiene Laarif

Quantitative modeling of inter-lesion and inter-organ variability of tumor size

Wednesday 15:10-16:40

II-06Jennifer Lang

Combining physiologically-based-pharmacokinetic modelling and a Bayesian method for prediction of ivabradine oral absorption and drug-drug interactions

Wednesday 15:10-16:40

II-07Silvia Maria Lavezzi

Pharmacokinetic Models for Drug and Metabolites Including First Pass Effects: A Priori and A Posteriori Identifiability Analysis

Wednesday 15:10-16:40

II-08Jean Lavigne

Population Pharmacokinetics of Piperacillin-Tazobactam Extended Infusions in Paediatric Population

Wednesday 15:10-16:40

II-09Jacob Leander

Development of a population pharmacokinetic model of verinurad used for simulations of various dosing scenarios in different populations

Wednesday 15:10-16:40

II-10Donghwan Lee

Effect of Pharmacokinetic Model Misspecification on Antibiotic Probability of Target Attainment Predicted by Monte Carlo Simulation

Wednesday 15:10-16:40

II-11Woo Yul Lee

Population pharmacokinetics of recombinant coagulation factor VIII in Korean hemophila A patients

Wednesday 15:10-16:40

II-12Soyoung Lee

Population Pharmacokinetic Analysis for Novel Acid Pump Antagonist DWP14012

Wednesday 15:10-16:40

II-13Hyun A Lee

A mechanism-based pharmacokinetic/pharmacodynamic model to evaluate the mutual relationships between YH4808, a novel K+-competitive acid blocker, and intragastric pH in humans

Wednesday 15:10-16:40

II-14So Jin Lee

The new era of pharmacokinetic/pharmacodynamic modeling and simulation in drug development in Korea

Wednesday 15:10-16:40

II-15Anja Lehmann

Toxicokinetic modelling of hepatotoxic pyrrolizidine alkaloids: a combined in silico, in vitro and in vivo approach

Wednesday 15:10-16:40

II-16Rory Leisegang

Establishing evidence for improved outcomes for HIV+ patients receiving antiretroviral drugs through home delivery

Wednesday 15:10-16:40

II-17Giulia Lestini

Handling dropouts in longitudinal observational studies – an illustration of a workflow from data preparation to model building and model diagnostics in Alzheimer’s disease

Wednesday 15:10-16:40

II-18Yisheng Li

A semi-mechanistic dose-finding design in oncology using pharmacokinetic/pharmacodynamic modeling

Wednesday 15:10-16:40

II-19Patrick Lilienthal

Mathematical modeling of RBC count dynamics after blood loss

Wednesday 15:10-16:40

II-20Dan Liu

Investigating Impacts of Model Parameters Correlations in Global Sensitivity Analysis: Determining the most influential parameters of a Minimal PBPK Model of Midazolam

Wednesday 15:10-16:40

II-21Feiyan Liu

Modeling inflammatory biomarker dynamics during clinical challenge studies with lipopolysaccharide

Wednesday 15:10-16:40

II-22Carolina Llanos-Paez

Implementation of event time distribution as a random effect in time-to-event analysis

Wednesday 15:10-16:40

II-23Rasmus Jansson Löfmark

Translational pharmacokinetic-pharmacodynamic modelling predicts human exposure target engagement

Wednesday 15:10-16:40

II-24Aurelie Lombard

Tumour size measurements: impact of inter-operator variability on model-based drug effect evaluation

Wednesday 15:10-16:40

II-25Dominik Lott

Prediction of exposure and effect on total lymphocyte count following long-term treatment of healthy subjects and lupus patients with the selective S1P1 receptor modulator cenerimod

Wednesday 15:10-16:40

II-26Qiang Lu

Population Pharmacokinetic Meta-Analysis of Dupilumab in Adult Atopic Dermatitis Patients, Asthma Patients, and Healthy Subjects

Wednesday 15:10-16:40

II-27Inga Ludwig

A Quantitative Approach to Assess Similarity of Adult and Pediatric Efficacy to Support Full or Partial Extrapolation in Pediatric Drug Development

Wednesday 15:10-16:40

II-28Ulrich Ruben Luecht

Physiologically based pharmacokinetic modeling approach to assess drug-drug interactions (DDI) between psychopharmaceuticals – focus on mirtazapine and venlafaxine

Wednesday 15:10-16:40

II-29Nicolas Luyckx

Improving the performances of clinical trial simulations in Simulo using compiled code

Wednesday 15:10-16:40

II-30Yassine Kamal Lyauk

Dose Finding in Clinical Development of 60 FDA-Approved Drugs Compared to the Learning versus Confirming Paradigm

Wednesday 15:10-16:40

II-31Sreenath M Krishnan

A combined population kinetic-pharmacodynamic-overall survival model for docetaxel and paclitaxel in the treatment of HER2–negative metastatic breast cancer patients

Wednesday 15:10-16:40

II-32Guangda Ma

Evaluating the influence of genotype on warfarin dose predictions made using a theory-based PKPD model.

Wednesday 15:10-16:40

II-33Panos Macheras

On the unphysical hypotheses in pharmacokinetics and oral drug absorption:Time to utilize instantaneous rate coefficients instead of rate constants

Wednesday 15:10-16:40

II-34Paolo Magni

Artificial intelligence and machine learning: just a hype or a new opportunity for pharmacometrics?

Wednesday 15:10-16:40

II-35Mats Magnusson

Population PK and PASI exposure-response modelling for Certolizumab pegol in patients with chronic plaque psoriasis

Wednesday 15:10-16:40

II-36Corinna Maier

Quantifying the uncertainty: informative decision-support in individualised chemotherapy

Wednesday 15:10-16:40

II-37Victor Mangas-Sanjuan

Population Pharmacokinetic and exposure-efficacy Markov modelling of enzymatic activity in Gaucher disease patients treated with enzyme replacement therapy

Wednesday 15:10-16:40

II-38Nicolás Marco Ariño

Pharmacodynamic modelling of pupil diameter after noxious stimulus in patients undergoing surgery

Wednesday 15:10-16:40

II-39Fatima Zahra Marok

Physiologically-based pharmacokinetic modeling of DPYD substrate 5-fluorouracil and its prodrug capecitabine

Wednesday 15:10-16:40

II-40Frederico Martins

Application of Physiologically Based Pharmacokinetic (PBPK) Modelling to Support First in Human dose selection.

Wednesday 15:10-16:40

II-41Paolo Mazzei

Prospective Evaluation of a Model-Based approach to select Phase 1 Dosing Regimen for MEN1309/OBT076, a novel antibody drug conjugate (ADC) targeting Ly75 antigen for the treatment of CD205-positive metastatic solid tumours and Non-Hodgkin lymphoma

Wednesday 15:10-16:40

II-42Mark Meerson

Quantitative systems pharmacology model of key intraneuronal pathways regulating toxic protein accumulation in Alzheimer’s disease

Wednesday 15:10-16:40

II-43Christophe Meille

Combining BLRM and safety PKPD models to improve decision making in a phase I dose escalation study: case study of PCA062, an antibody drug conjugate targeting P-Cadherin

Wednesday 15:10-16:40

II-44Nicola Melillo

Global sensitivity analysis of a physiologically based pulmonary absorption model

Wednesday 15:10-16:40

II-45France Mentré

New version of PFIM for optimal design in nonlinear mixed effects models using R S4

Wednesday 15:10-16:40

II-46Matilde Merino-Sanjuán

Impact of ABC gene single nucleotide polymorphisms in population pharmacokinetic of capecitabine and its metabolites 5′-deoxy-5-fluorouridine (5′-DFUR) 5-fluorouracil (5-FU) in patients with colorectal cancer

Wednesday 15:10-16:40

II-47Danica Michalickova

Pharmacokinetics of phenobarbital in neonates on extracorporeal membrane oxygenation

Wednesday 15:10-16:40

II-48Robin Michelet

A workflow for application of the general pharmacodynamic interaction model on high-throughput combinatorial data in order to identify, quantify and characterise drug combinations that can overcome multi-drug-resistance

Wednesday 15:10-16:40

II-49Iris Minichmayr

Impact of genetic variants of UGT1A1 on myelosuppression during irinotecan therapy

Wednesday 15:10-16:40

II-50Jonathan Mochel

A Physiologically-Based Pharmacokinetic (PBPK) Model for the Prediction of Levodopa (L-dopa) Disposition in Plasma and Various Brain Compartments Across Species

Wednesday 15:10-16:40

II-51

Biotest’s Pentaglobin® in adults and neonates (term and preterm) – A PBPK approach

Wednesday 15:10-16:40

II-52Camille Riff

Population Pharmacokinetics of Rituximab in patients with Chronic Lymphocytic Leukemia

Wednesday 15:10-16:40

II-53Anna Mc Laughlin

Model-informed precision dosing for tamoxifen therapy in breast cancer patients: Comparison of different target attainment metrics

Wednesday 15:10-16:40

II-54Flora Musuamba Tshinanu

Dose optimization based on control and system theory: Case of Meropenem

Wednesday 15:10-16:40

II-55Tadakatsu Nakamura

A Model-Based Meta-Analysis (MBMA) of Efficacy of Different Drugs for Postmenopausal Vasomotor-Symptoms

Wednesday 15:10-16:40

II-56Ricardo Nalda-Molina

Evaluation of the predictive performance and the model adequacy of four population pharmacokinetic models of adalimumab in patients with inflammatory bowel disease.

Wednesday 15:10-16:40

II-57Srividya Neelakantan

Population Pharmacokinetic/Pharmacodynamic Modeling of PF-06480605, an Anti-TL1A Antibody, in Healthy Subjects and Ulcerative Colitis Patients

Wednesday 15:10-16:40

II-58Ida Neldemo

The tumor time-course predicts the overall survival in non-small cell lung cancer patients treated with atezolizumab in a large Phase I study: an evaluation of using different censoring times

Wednesday 15:10-16:40

II-59Bernard Ngara

A Semi-mechanistic population pharmacokinetic model quantifying hair concentrations of ritonavir-boosted atazanavir. A study of HIV infected Zimbabweans adolescents.

Wednesday 15:10-16:40

II-60Laurent Nguyen

Pharmacokinetic time-dependency and covariates modelling of Isatuximab monoclonal antibody in multiple myeloma patients: analysis from pooled phase I/II & phase III studies

Wednesday 15:10-16:40

II-61Laura Zwep

Hierarchical group LASSO with random effects: identification of high-dimensional omics-drug interactions predictive of treatment response in patient-derived tumor growth data

Wednesday 15:10-16:40

II-62Joakim Nyberg

Implicit and efficient handling of missing covariate information using full random effects modelling

Wednesday 15:10-16:40

II-63Boram Ohk

Population pharmacokinetic analysis of tacrolimus: The role of integrative pharmacogenetics and pharmacometabolomics

Wednesday 15:10-16:40

II-64Andrés Olivares-Morales

Bayesian pharmacokinetic (PK) and pharmacodynamic (PD) modelling of the qEEG response to a selective GABAA a5 receptor modulator in rats to inform its use as a translational biomarker

Wednesday 15:10-16:40

II-65Sean Oosterholt

Model-based optimisation of N-acetylcysteine for the treatment of paracetamol overdose

Wednesday 15:10-16:40

II-66Fernando Ortega

Developing a head and neck cancer model to assess the effect of radiotherapy on tumour growth inhibition and regrowth

Wednesday 15:10-16:40

II-67Taniya Paiboonvong

Development of physiologically based pharmacokinetic model of sitafloxacin in plasma and epithelial lining fluid

Wednesday 15:10-16:40

II-68Semra Palic

Neopterin dynamics in pediatric patients after miltefosine treatment of visceral leishmaniasis

Wednesday 15:10-16:40

II-69Robert Palmér

A novel joint modelling approach to estimating treatment effects on COPD exacerbations in the presence of differential discontinuations

Wednesday 15:10-16:40

II-70Hyeonsoo Park

A population pharmacokinetic model of Glimepiride(Amaryl®)

Wednesday 15:10-16:40

II-71Christophe Passot

A kinetic-pharmacodynamic model of palbociclib reveals an influence of body weight on neutropenia onset.

Wednesday 15:10-16:40

II-72Nathalie Perdaems

Translational PK-RO modelling for a mAb to predict the outcome of the first in human study

Wednesday 15:10-16:40

II-73Carlos Perez-Ruixo

Exposure-response relationships of the efficacy and safety of apalutamide (APA) in men with non-metastatic castration-resistant prostate cancer (nmCRPC)

Wednesday 15:10-16:40

II-74Soumya Perinparajah

Pharmacodynamics of rituximab on B cells in paediatric post-HSCT patients with EBV

Wednesday 15:10-16:40

II-75Thomas Peyret

Development of a Quantitative Systems Pharmacology Model to Support Dosing of rhPTH(1-84), a Recombinant Human Parathyroid Hormone, in Adult Patients with Hypoparathyroidism

Wednesday 15:10-16:40

II-76Chiara Piana

Development of a translational pharmacokinetic-biomarker-efficacy model in mouse to support dose recommendation in human

Wednesday 15:10-16:40

II-77Philippe Pierrillas

PK-PD modelling of C4 concentrations after administration of a FXR agonist in healthy volunteers and Hepatitis B patients

Wednesday 15:10-16:40

II-78Nikhil Pillai

Single objective genetic algorithm based approach for optimal population pharmacokinetic/pharmacodynamics (PK/PD) model selection for tumor growth response

Wednesday 15:10-16:40

II-79Vikram Prabhakar

QSP Model of Rheumatoid Arthritis, capturing range of clinical responses to Methotrexate and anti-TNF-a therapies

Wednesday 15:10-16:40

II-80Sudeep Pradhan

Evaluation of study designs to test the intact nephron hypothesis

Wednesday 15:10-16:40

II-81Mélanie Prague

In Silico Clinical Trials for Evaluation of HIV Short-Cycle strategies

Wednesday 15:10-16:40

II-82Luna Prieto Garcia

Physiologically-based pharmacokinetic model for itraconazole and its metabolites: the importance of parameter sensitivity analysis

Wednesday 15:10-16:40

II-83Alicja Puszkiel

Population pharmacokinetic analysis of tamoxifen and its six metabolites in breast cancer patients: Quantification of the impact of genetic polymorphisms and co-medications on tamoxifen metabolism

Wednesday 15:10-16:40

II-84Rajith Rajoli

PBPK Modelling of Atovaquone Long-acting Injectable Formulations

Wednesday 15:10-16:40

II-85Chetan Rathi

Model-Informed selection of doses and sample size for a Phase 2a POC study of GSK3640254, a next generation HIV-1 maturation inhibitor

Wednesday 15:10-16:40

II-86Michael Reed

Evaluation of competitive differentiation of novel therapies and the impact of patient variability on efficacy in a psoriasis QSP platform

Wednesday 15:10-16:40

II-87Javier Reig-López

Validation of a Semi-mechanistic model with first-pass metabolism, two metabolic pathways and intestinal efflux transporter implemented in PhysPK biosimulation software.

Wednesday 15:10-16:40

II-88Isabel Reinecke

Levonorgestrel-Containing Contraceptives: Comparison of Daily Doses and Exposure for Various Routes of Administration by an Integrated Population Pharmacokinetic Analysis

Wednesday 15:10-16:40

II-89Dinko Rekic

Higher Febuxostat Exposure observed in Japanese Compared to Caucasian Subjects Independent of Bodyweight

Wednesday 15:10-16:40