Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (98)

II-01

Impact of OATP1B1 Polymorphism on Pravastatin Pharmacokinetics during Pregnancy; Physiologically Based Pharmacokinetic model Prediction

Wednesday 15:35-17:00

II-02Tariq Abdulla

Using Simcyp Designer to extend a PBPK-QSP Model of Warfarin to Target Binding

Wednesday 15:35-17:00

II-03Oliver Ackaert

Exposure Response Analysis of the Effect of Loperamide on the Cardiac Repolarization Interval in Healthy Adult Subjects

Wednesday 15:35-17:00

II-04Eleni Alexopoulou

Population pharmacokinetics of budesonide (BDS) and its two main metabolites 6β-hydroxy-budesonide(6OH-BDS) and 16α-hydroxy-prednisolone(16OH-PREDN) with and without hyperhydration effect

Wednesday 15:35-17:00

II-05Mahmoud Ali

Evaluation of the robustness of methods for model-based bioequivalence analysis for biosimilars: Clenoliximab as a case study

Wednesday 15:35-17:00

II-06Simon Arsène

In silico trials platform for exploration of trial design space in atopic dermatitis

Wednesday 15:35-17:00

II-07Peter Ashcroft

Mechanistic PKPD modelling of targeted protein degradation to improve compound selection in drug discovery and translation to the clinic

Wednesday 15:35-17:00

II-08Rami Ayoun Alsoud

Model-based interspecies scaling and impact of anti-drug antibodies on the pharmacokinetics of the therapeutic protein CB 4332

Wednesday 15:35-17:00

II-09Nicolas Azzopardi

Mechanistic model of oxytocin/vasopressin-stimulated GPCR.

Wednesday 15:35-17:00

II-10Dana Bakir

Investigating Interoccasion Variability and Estimation Methods

Wednesday 15:35-17:00

II-11Pavel Balazki

4ß-OH Cholesterol as endogenous biomarker for CYP3A4 inducer DDI studies – a PBPK-QSP platform for in silico compound testing

Wednesday 15:35-17:00

II-12Catalina Barcelo

Use of informative prior distributions from mepolizumab data to support depemokimab PKPD model analysis

Wednesday 15:35-17:00

II-13Roberta Bartolucci

Exposure-Response Analysis of the Macitentan Effects on NT-proBNP and WHO functional class in adult patients with Pulmonary Arterial Hypertension

Wednesday 15:35-17:00

II-14Mattia Berton

Physiologically based pharmacokinetic modelling to investigate the impact of obesity on the pharmacokinetics of rilpivirine, efavirenz, and etravirine

Wednesday 15:35-17:00

II-15Sara Bettonte

Onset and disappearance of induction on CYP3A4 and UGT1A1 substrates using PBPK modelling

Wednesday 15:35-17:00

II-16Davide Bindellini

Understanding the physiology of the hypothalamic-pituitary-adrenal axis to optimise cortisol replacement therapy: A quantitative modelling framework

Wednesday 15:35-17:00

II-17Peter Bloomingdale

An Artificial Intelligence Framework for Optimal Drug Design

Wednesday 15:35-17:00

II-18Ivan Borisov

An Algorithm to Generate Virtual Patients Cohort for a Model of Solid Tumor Treatment

Wednesday 15:35-17:00

II-19Rolien Bosch

Linking 4GI Glucose Homeostasis and Hall Body Composition Models to study GLP-1R Agonist effects on glucose and body weight

Wednesday 15:35-17:00

II-20Thomas Bouillon

Comparison and selection of dosing regimens by discretization, optimizing efficacy and evaluating exposure demonstrated for KAE609 (Cipargamin)

Wednesday 15:35-17:00

II-21THAM THI BUI

Development of a physiological-based pharmacokinetic model for sacubitril and its metabolite

Wednesday 15:35-17:00

II-22Núria Buil Bruna

Understanding onset and extent of response using different clinical endpoints in Atopic Dermatitis

Wednesday 15:35-17:00

II-23Elisa Calvier

PBPK modelling of the DDI between a Drug X and gemfibrozil

Wednesday 15:35-17:00

II-24Simona Catozzi

Inter-species and in vitro-in vivo scaling for quantitative modeling of whole-body drug pharmacokinetics in patients: Application to the anticancer drug oxaliplatin

Wednesday 15:35-17:00

II-25Geraldine Celliere

Comparison of a typical PK/PD model versus a mechanistic QSP model to predict the Phase II of a PSCK9 inhibitor, using MonolixSuite

Wednesday 15:35-17:00

II-26JunSeok Cha

A Pharmacokinetic/Pharmacodynamic Model of Recombinant Batroxobin

Wednesday 15:35-17:00

II-27Marylore Chenel

Physiologically based pharmacokinetic (PBPK) modeling of the oral absorption of 5-flucytosine to support further development of a sustained-release formulation for the treatment of cryptococcal meningoencephalitis

Wednesday 15:35-17:00

II-28Wendy Chu

Disease-specific differences in pharmacokinetics of paromomycin and miltefosine between post-kala-azar dermal leishmaniasis and visceral leishmaniasis patients in Eastern Africa

Wednesday 15:35-17:00

II-29Brian Cicali

Long-acting formulation drug-drug interactions: evaluating the importance of timing using a subcutaneous levonorgestrel PBPK example

Wednesday 15:35-17:00

II-30Michael Cloesmeijer

Physiologically-based pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) and recombinant FIX (rFIX) to characterize extravasation and binding to type IV collagen

Wednesday 15:35-17:00

II-31Aude Coumau

Population pharmacokinetic modelling to characterize (es)citalopram exposure in a large cohort of psychiatric patients

Wednesday 15:35-17:00

II-32Jared Cui

Incorporating complex drug PK with multiple binding targets into a QSP model to predict combined PD effects

Wednesday 15:35-17:00

II-33Marina Cuquerella Gilabert

Title: Development of a Compartmental Advanced Physiologically based Dissolution, Absorption and Transit (CA-PhysDAT) model in PhysPK

Wednesday 15:35-17:00

II-34Anna Dari

Mechanistic Modeling Projections of Antibody Persistence After Homologous Booster Regimens of COVID-19 Vaccine Ad26.COV2.S in Humans

Wednesday 15:35-17:00

II-35Pieter-Jan De Sutter

Comparison of monoclonal antibody disposition predictions between different PBPK platforms

Wednesday 15:35-17:00

II-36Wilbert de Witte

Whole-body PBPK with tissue TMDD modelling to predict determining parameters of target occupancy in tissues

Wednesday 15:35-17:00

II-37Neel Deferm

Development of a physiologically-based pharmacokinetic model of enzalutamide, a strong CYP3A4 inducer

Wednesday 15:35-17:00

II-38Cleo Demeester

Implementation of Oral Drug Absorption in Older Adults in the Physiologically Based Pharmacokinetic (PBPK) Modelling Platforms

Wednesday 15:35-17:00

II-39Abdallah Derbalah

Characterization of the hepatic distribution of oligonucleotide therapeutics using a cross-species biologics PBPK model

Wednesday 15:35-17:00

II-40Qian Dong

Population pharmacokinetic analysis of nonlinear behavior of adefovir

Wednesday 15:35-17:00

II-41Ilse Dubbelboer

Wednesday 15:35-17:00

II-42Janna Duong

A dermal physiologically-based pharmacokinetic (PBPK) model of clobetasol propionate to predict systemic exposure in eczema and dermatitis patients

Wednesday 15:35-17:00

II-43Marwa Elhefnawy

Quantifying the rate of blood glucose changes over the acute stage of ischemic stroke among patients with diabetes.

Wednesday 15:35-17:00

II-44Jacqueline Ernest

A translational site-of-action PK-PD modeling platform to propose treatment shortening regimens for tuberculosis

Wednesday 15:35-17:00

II-45Edoardo Faggionato

Assessing insulin sensitivity, glucose effectiveness, and β-cell responsivity using an integrated glucose, insulin, and C-peptide minimal model

Wednesday 15:35-17:00

II-46Undine Falkenhagen

Can quantitative systems pharmacology guide precision dosing? An illustrative warfarin-INR example

Wednesday 15:35-17:00

II-47Alan Faraj

A model for evaluation of novel on-demand treatment of bleeding events in hemophilia subjects

Wednesday 15:35-17:00

II-48Anna Fochesato

A minimal PBPK model to unveil anti-tuberculosis drug distribution in pulmonary lesions: a blueprint for improving efficacy screenings.

Wednesday 15:35-17:00

II-49Sylvaine Galiegue

Derisking the development of rilzabrutinib, a BTK inhibitor currently in phase III, with a PBPK model in lieu of some clinical studies

Wednesday 15:35-17:00

II-50María García-Cremades

Risk stratification algorithm for MDR-TB patients based on pooled individual data analysis.

Wednesday 15:35-17:00

II-51Maite Garraza Obaldia

Semi-mechanistic model of the Haemodynamic effects of propofol and remifentanil administered in combination to patients undergoing general anaesthesia

Wednesday 15:35-17:00

II-52Frédéric Gaspar

Population pharmacokinetics of apixaban in a real-life hospitalized population

Wednesday 15:35-17:00

II-53Amira Ghoneim

Modeling of the Pharmacokinetics of the Selective Orexin-1 Receptor Antagonist ACT-539313 with Auto-Inhibition

Wednesday 15:35-17:00

II-54Audrick GIBERT

PK/PD of unfractionned heparin during cardiopulmonary bypass: an individual patient data meta-analysis of two studies

Wednesday 15:35-17:00

II-55Janice Goh

A translational toolkit to predict clinical Phase IIb/III outcomes from preclinical mouse studies

Wednesday 15:35-17:00

II-56

Model-Based Translational Rapamycin Dose Selection to Promote Engraftment and Expansion of the Engineered Regulatory T cell (EngTreg) product GNTI-122 in Human

Wednesday 15:35-17:00

II-57Berfin Gülave

P-glycoprotein mediated drug-drug interaction at the blood-brain barrier on morphine brain distribution

Wednesday 15:35-17:00

II-58Andrea Guzmán

Individualized Tacrolimus dosing in pediatric kidney transplantation: identification of new genomic, proteomic and metabolomic biomarkers and PhysPK® development of PBPK-based predictive models, simulations and applications in different phamacogenomic subpopulations.

Wednesday 15:35-17:00

II-59Sofia Guzzetti

An integrated modelling approach for targeted degradation: insights on optimisation, data requirements and PKPD predictions from semi- or fully-mechanistic models and exact steady state solutions

Wednesday 15:35-17:00

II-60Chihiro Hasegawa

Exploring simplification of a target-mediated drug disposition (TMDD) model for bispecific antibodies for potential application to data-driven modelling

Wednesday 15:35-17:00

II-61Sara Carolina Henriques

Development of a joint dissolution and pharmacokinetic model of propafenone and its hydroxylated metabolite

Wednesday 15:35-17:00

II-62Yannick Hoffert

An automated multi-model selection algorithm to improve precision dosing of tacrolimus in liver, lung, and bowel transplant recipients

Wednesday 15:35-17:00

II-63Ana Homšek

Population pharmacokinetic model of infliximab in patients with fistulising Crohn’s disease

Wednesday 15:35-17:00

II-64Vincent Hurez

Development of a primary Sjogren’s Syndrome (pSS) quantitative systems pharmacology (QSP) model linking mechanistic pathways to clinical scores.

Wednesday 15:35-17:00

II-65Manuel Ibarra

Enhancing the predictive accuracy of PBPK models for drug concentrations in tissues: accounting for the impact of relative distribution of blood flow

Wednesday 15:35-17:00

II-66Vijay Ivaturi

Novel convolution-based In vitro-In vivo correlation (IVIVC) model with time scaling and bioavailability sub-models for, JORNAY PM®, a methylphenidate hydrochloride delayed-release and extended-release capsule

Wednesday 15:35-17:00

II-67Nattapon Jaisupa

A physiologically-based pharmacokinetic model for prediction of cannabidiol pediatric dose

Wednesday 15:35-17:00

II-68Masoud Jamei

Application of a PBPK Model to Predict the Required Ceftazidime Concentration and Duration in Maternal and Umbilical Plasma Prior to Caesarean Section in Virtual Pregnant Women with Different Renal Function

Wednesday 15:35-17:00

II-69SEONGMEE JEONG

Human effective dose prediction of analgesic drug using translational PK-PD modeling

Wednesday 15:35-17:00

II-70Woojin Jung

Fractal kinetic implementation in population modeling

Wednesday 15:35-17:00

II-71Soo-Min Jung

Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of Nesuparib (JPI-547) in Patients with Advanced Solid Tumor

Wednesday 15:35-17:00

II-72Daniel Kaschek

Joint modeling with Monolix using IQR Tools

Wednesday 15:35-17:00

II-73Atefeh Kazeroonian

A first-ever mechanistic disease model of IgG4-related disease identifies high-potential therapy targets

Wednesday 15:35-17:00

II-74heungjo Kim

Population pharmacokinetics of intravenous midazolam in critically ill patients supported with extracorporeal membrane oxygenation therapy

Wednesday 15:35-17:00

II-75Bastian Kister

Quantitative Systems Pharmacology of Interferon Alpha Administration and its induced cellular response in mice

Wednesday 15:35-17:00

II-76Christine Juliane Kleist

A PKPD model of favipiravir and ribavirin in Lassa virus infected mice

Wednesday 15:35-17:00

II-77Niklas Korsbo

DeepPumas for automatic discovery of individualizable functions governing longitudinal patient outcomes

Wednesday 15:35-17:00

II-78Anis Krache

Modelling selective cell targeting through avidity to inform bispecific antibody discovery and development

Wednesday 15:35-17:00

II-79Hanna Kunina

Blood glucose profile evaluation with model-based approach using continuous glucose monitoring data

Wednesday 15:35-17:00

II-80Jialin Mao

Shared Learning from a Physiologically-Based Pharmacokinetic Modeling Strategy for Human Pharmacokinetics Prediction through Retrospective Analysis of Genentech Compounds

Wednesday 15:35-17:00

II-81Francois Mercier

Bridging the gap between two-stage and joint models: The case of tumor growth inhibition and overall survival models

Wednesday 15:35-17:00

II-82Andreas Noack

On the error of the Laplace approximation when lags and duration parameters have between-subject variation

Wednesday 15:35-17:00

II-83Rune Overgaard

Wednesday 15:35-17:00

II-84Teun Post

Innovative adaptive dose simulations in NONMEM to allow simulation-based model evaluation of titration-based dosing, applied to a population dose-hemoglobin model for Jesduvroq (daprodustat)

Wednesday 15:35-17:00

II-85Mar Ribera I Armengol

Application of Structural Identifiability Analysis and Parametrisation of a Linear Mixed Effects Mirabegron Model

Wednesday 15:35-17:00

II-86Elena Righetti

A mechanistic model of α-synuclein aggregation and degradation to bridge in vitro and in vivo research on Parkinson’s disease.

Wednesday 15:35-17:00

II-87Sergio Sánchez Herrero

Integrating Python optimization algorithms inside PhysPK® (PK/PD/PBPK) software for improving PK estimation methods.

Wednesday 15:35-17:00

II-88Rajendra Singh

A Time-to-event Modeling Approach Supporting the Safety Profile of New Deutetrabenazine (AUSTEDO) Titration Schemes in Patients with Tardive Dyskinesia and Huntington’s Disease

Wednesday 15:35-17:00

II-89Nelleke Snelder

From glomerular filtration rate to renal composite endpoint: an integrated time-to-event analysis of finerenone in phase 3 studies.

Wednesday 15:35-17:00

II-90Sara Soufsaf

An Exploratory Analysis of the Performance of Methylphenidate Regimens Based on a PKPD Model of Dopamine and Norepinephrine Transporter Occupancy

Wednesday 15:35-17:00

II-91Britta Steffens

Enhanced pharmacometrics model utilizes heart rate to monitor thyroid function in pediatric Graves’ disease under pharmacotherapy

Wednesday 15:35-17:00

II-92Mohamed Tarek

Marginal No-U-Turn Sampler for Bayesian Analysis in Pharmacometrics

Wednesday 15:35-17:00

II-93Mohamed Tarek

Fast cross-validation for Bayesian inference using proposals on a linear subspace

Wednesday 15:35-17:00

II-94Franziska Thoma

A fully hierarchical Bayesian approach to sequentially update population parameter uncertainty in MIPD

Wednesday 15:35-17:00

II-95Monika Twarogowska

A method to correct VPC bias due to non-random dropout via censored data addition, using the MonolixSuite

Wednesday 15:35-17:00

II-96Martijn van Noort

Two new user-friendly approaches to assess pharmacometric model identifiability

Wednesday 15:35-17:00

II-97Yanlin Wang

Development of a Population Pharmacokinetic Model to Describe the Pharmacokinetics of Aripiprazole 2-Month Ready-to-Use, a Novel Long-Acting Injectable Formulation of Aripiprazole for Administration Once Every 2 Months

Wednesday 15:35-17:00

II-98Jen-Hao (Eric) Wu

Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia – results of study ITCC-059

Wednesday 15:35-17:00