Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (64)

I-01João Abrantes

ADaMO: End-to-end automation of Pharmacometric modelling in drug development, from dataset building to output generation

Wednesday 09:45-11:15

I-02Nicolas Azzopardi

Mechanistic model of contrast-enhanced ultrasound in colorectal cancer metastasis.

Wednesday 09:45-11:15

I-03Freya Bachmann

Computing Optimal Drug Dosing with OptiDose: Implementation in NONMEM

Wednesday 09:45-11:15

I-04Aliénor Bergès

Model informed drug development to accelerate clinical development in life cycle innovation

Wednesday 09:45-11:15

I-05Monir Bertayli

Dose determination of morphine to investigate the analgesic effects of morphine and pregabalin in healthy subjects using a combined NONMEM model

Wednesday 09:45-11:15

I-06Mattia Berton

Repository of model parameters for physiologically based pharmacokinetic modelling in obese validated against triazolam and caffeine observed data

Wednesday 09:45-11:15

I-07Jantine Brussee

Population PK modelling for the iminosugar lucerastat supports dose adaptation in patients with Fabry disease and moderate to severe renal impairment

Wednesday 09:45-11:15

I-08Laura Bukkems

Relationship between factor VIII activity levels and bleeding for rFVIII-SingleChain in patients with severe hemophilia A

Wednesday 09:45-11:15

I-09Myriam Chartoire

Investigation of the design of the capsaicin cough challenge test

Wednesday 09:45-11:15

I-10Chao Chen

The area under the effect curve as a preclinical-to-clinical translation tool for predicting therapeutic dose of anti-infectives

Wednesday 09:45-11:15

I-11Henrik Cordes

Species-specific Expression Databases for Physiologically Based Pharmacokinetic Modeling

Wednesday 09:45-11:15

I-12Vincent Croixmarie

Dose selection and adaptation strategy in renal impaired patients for a phase 2 study with a Clinical Trial Simulation strategy

Wednesday 09:45-11:15

I-13Anna Dari

Quantifying the Persistence of Immunogenicity After a Single Dose of Ad26.COV2.S in Humans Using a Mechanistic Modeling & Simulation Approach

Wednesday 09:45-11:15

I-14Alessandro Di Deo

Evaluation of the pharmacokinetics of tideglusib in congenital and childhood myotonic dystrophy type 1 using Bayesian priors

Wednesday 09:45-11:15

I-15Alan Faraj

Model-informed dose selection in phase-3 trials for prophylactic treatment with dalcinonacog alfa in adult and pediatric hemophilia B patients

Wednesday 09:45-11:15

I-16Alan Faraj

A joint ketamine and esketamine exposure-response model of MADRS score in major depressive disorder to enable informed trial design for candidate drugs with similar mode of action

Wednesday 09:45-11:15

I-17Thomas Frank

Population pharmacokinetic/pharmacodynamic modeling to demonstrate comparability of exposure and activity of insulin aspart Sanofi

Wednesday 09:45-11:15

I-18Aline Fuchs

The human FcRn transgenic mice Tg32 as a model for early assessment and prediction of human pharmacokinetics of monoclonal antibodies

Wednesday 09:45-11:15

I-19Iztok Grabnar

Pharmacokinetic-pharmacodynamic model of fentanyl sedation in children with severe acute bronchiolitis

Wednesday 09:45-11:15

I-20Mélanie Guhl

Computation of standard errors at finite distance in non linear mixed effects models

Wednesday 09:45-11:15

I-21

A Bounded Integer Approach to Evaluate AIMS Score for Austedo in Patients with Tardive Dyskinesia

Wednesday 09:45-11:15

I-22Seiichi Hayato

Population pharmacokinetics and exposure-response analyses of amyloid PET SUVr and plasma biomarkers Aβ42/40 ratio and p-tau181 for lecanemab in subjects with early Alzheimer’s disease

Wednesday 09:45-11:15

I-23Chih-hsuan Hsin

Hepatic impairment affects pharmacokinetics and pharmacodynamics of selatogrel, a novel subcutaneous P2Y12 receptor antagonist

Wednesday 09:45-11:15

I-24Laura Iavarone

Application of the Area Under the Effect Curve as in vivo efficacy driver in Visceral Leishmaniasis

Wednesday 09:45-11:15

I-25Woojin Jung

Containerized NONMEM and its assistant software in R development environment

Wednesday 09:45-11:15

I-26Angela Khodzhayev

Esophageal Eosinophil Count and the Endoscopic Reference Score Remodeling Subscore Do Not Correlate in Placebo Treated Eosinophilic Esophagitis Patients: Phase 2 Proof-of-Concept and Phase 3 TREET Studies

Wednesday 09:45-11:15

I-27Jane Knöchel

Accelerating clinical development of a novel PCSK9 antisense oligonucleotide using semi-mechanistic pharmacodynamic modelling

Wednesday 09:45-11:15

I-28Silvia Maria Lavezzi

Translational pharmacology benchmarking of a novel drug candidate for an autoimmune disease

Wednesday 09:45-11:15

I-29Olivier Le Tilly

Non-linear pharmacokinetics of eculizumab in atypical haemolytic uremic syndrome

Wednesday 09:45-11:15

I-30Feiyan Liu

A system pharmacology Boolean network model for the TLR4-mediated host response in early sepsis

Wednesday 09:45-11:15

I-31Igor Locatelli

A Bayesian mixed treatment comparison meta-analysis of pulmonary arterial hypertension therapies

Wednesday 09:45-11:15

I-32Nicolas Luyckx

Campsis: A generic, easy-to-use and intuitive PK/PD simulation platform based on R packages RxODE and mrgsolve

Wednesday 09:45-11:15

I-33Vincent Madelain

Multicompartmental PKPD model to inform active exposure of nucleic acid therapeutic candidate in CNS disease

Wednesday 09:45-11:15

I-34Parsshava Mehta

Application of interspecies PBPK modeling to characterize BBB permeability and assess target site exposure-response using levetiracetam as model drug

Wednesday 09:45-11:15

I-35Frano Mihaljevic

Development of a level A in vitro/in vivo correlation (IVIVC) using applications of the MonolixSuite

Wednesday 09:45-11:15

I-36Anna Mishina

Simulation of Rituximab and Natalizumab biomarker efficacy using simplified QSP model of B- and T- lymphocyte dynamics in Multiple Sclerosis

Wednesday 09:45-11:15

I-37Joo Young Na

Population pharmacokinetic analysis of omeprazole according to CYP2C19 polymorphism in elderly subjects

Wednesday 09:45-11:15

I-38Chiara Nicolò

MS TreatSim: A clinical trial simulator for Relapsing-remitting Multiple Sclerosis

Wednesday 09:45-11:15

I-39Marije Otto

Application of Item Response Theory in Early Phase Clinical Trials: Utilization of a Reference Model to Analyse the Montgomery-Åsberg Depression Rating Scale.

Wednesday 09:45-11:15

I-40Theodoros Papathanasiou

PKPD Exploratory Graphics (xGx) Cheat Sheet

Wednesday 09:45-11:15

I-41Tiffany Pela

Quality of Life and Symptom Burden Among Patients With Eosinophilic Esophagitis in a Real-World Setting

Wednesday 09:45-11:15

I-42Carlos Perez-Ruixo

Population pharmacokinetic modelling of selexipag and its active metabolite after oral and intravenous administration in adult pulmonary arterial hypertension patients

Wednesday 09:45-11:15

I-43Christoph Pfaffendorf

Population pharmacokinetic model of atovaquone in infants to adults

Wednesday 09:45-11:15

I-44Thao Nguyen Pham

Combining aggregate data and individual patient/subject data in model-based meta-analysis: An illustrative case study of tofacitinib in rheumatoid arthritis patients

Wednesday 09:45-11:15

I-45Elodie Plan

Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357 treatment

Wednesday 09:45-11:15

I-46Anne Ravix

Population pharmacokinetic study of lacosamide in children and adults with epilepsy

Wednesday 09:45-11:15

I-47Mar Ribera I Armengol

A perspective on the kinetics of the oral administration of Mirabegron to treat overactive bladder in spinal cord injury patients

Wednesday 09:45-11:15

I-48Christelle Rodrigues

Using preclinical data to predict human pharmacokinetics of monoclonal antibodies for first-in-human dose setting: A review of five internal case studies

Wednesday 09:45-11:15

I-49Karine Rodriguez-Fernandez

External validation of a population pharmacokinetic model of adalimumab in patients with hidradenitis suppurativa

Wednesday 09:45-11:15

I-50Viktor Rognås

An integrated semi-mechanistic model to predict the outcome of drug-target effects on the erythropoietic system

Wednesday 09:45-11:15

I-51Sergio Sánchez Herrero

Ground-breaking software for modelling, simulation, optimization, estimation and validation applications in drug development timeline processes.

Wednesday 09:45-11:15

I-52Marina Savelieva

Pharmacometrics and Integrated Evidence Generation: example of ligelizumab in Chronic Spontaneous Urticaria

Wednesday 09:45-11:15

I-53Daniel Seeler

Towards a qualitative systems biology model to study the effect of blood flow responsive CCM and NO signaling on endothelial cell morphology

Wednesday 09:45-11:15

I-54Sejung Hwang

Population pharmacokinetic analysis to investigate the effect of ethnicity for extrapolating data from Caucasians to Koreans in eslicarbazepine acetate therapy

Wednesday 09:45-11:15

I-55Alexander Solms

Reduced FXI levels do not appear to increase bleeding risk in End-Stage Kidney Disease patients – results from an exploratory PK/PD and ER analysis of FXI-ASO

Wednesday 09:45-11:15

I-56Gilles Tiraboschi

Population Pharmacokinetic and Pharmacodynamic Analyses of Olipudase alfa in Adult and Pediatric Patients with the rare Acid Sphingomyelinase Deficiency (Niemann-Pick) lysosomal storage disease

Wednesday 09:45-11:15

I-57Thi Quyen Tran

Population pharmacokinetics of a truncated milk fat globule-EGF factor 8 (NP-011) for optimal dose prediction on liver fibrosis

Wednesday 09:45-11:15

I-58Pauline Traynard

Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin and SAS.

Wednesday 09:45-11:15

I-59carla troisi

Population pharmacokinetics of continuous infusion ampicillin in the treatment of enterococcal infections in adult hospitalised patients

Wednesday 09:45-11:15

I-60Monika Twarogowska

A library of parent-metabolite models for the MonolixSuite

Wednesday 09:45-11:15

I-61Paul van den Berg

Finerenone Dose-Exposure-Response for the Primary Kidney Outcome in FIDELIO-DKD Phase III: Population Pharmacokinetic and Time-to-Event Analysis

Wednesday 09:45-11:15

I-62Marinda van de Kreeke

Identifiability of drug effects in turn-over models with increasing complexity

Wednesday 09:45-11:15

I-63Xiaofeng Wang

Exposure–response modelling of aripiprazole and brexpiprazole in adults and adolescents with schizophrenia to support extrapolation of efficacy in adolescents

Wednesday 09:45-11:15

I-64Zhigang Wang

Higher clearance of therapeutic antibodies is associated with worse endoscopic outcomes in patients with Crohn’s disease

Wednesday 09:45-11:15