Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (108)

I-001Freya Bachmann

Prospective dose optimization for individual patients by successive application of empirical Bayesian estimation and OptiDose including uncertainty quantification: Application to pediatric Graves’ Disease

Wed, Jun 3, 2026 10:30AM–12:00PM

I-002Wendy Chu

Female contraceptive cover duration for miltefosine-containing regimens for the treatment of leishmaniasis

Wed, Jun 3, 2026 10:30AM–12:00PM

I-003Astrid Heida

Structured fit-for-purpose evaluation of model-informed precision dosing of mycophenolic acid and tacrolimus in pediatric patients with renal disease

Wed, Jun 3, 2026 10:30AM–12:00PM

I-004Toni Michael

POPULATION PHARMACOKINETIC-PHARMACODYNAMIC MODELLING OF FOLLICLE-STIMULATING HORMONE AND INHIBIN-B TO PREDICT OVARIAN RESPONSE TO FOLLITROPIN ALFA IN IN VITRO FERTILISATION PATIENTS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-005Paulina Okuńska

Individualized Vancomycin Dosing Using Bayesian Modeling in Pediatric Patients with Lymphomas and Leukemias

Wed, Jun 3, 2026 10:30AM–12:00PM

I-006Keith T. Schmidt

Pharmacometric evaluation of extended interval dosing of IV-administered nivolumab using an established popPK model and sparse trough sampling: REFINE Nivolumab Cohort Interim Pharmacokinetic Analysis

Wed, Jun 3, 2026 10:30AM–12:00PM

I-007Alma Tan

OPTIMIZING DOSING REGIMENS OF TRASTUZUMAB EMTANSINE AND TRASTUZUMAB DERUXTECAN: A MODEL-INFORMED COST-SAVING APPROACH

Wed, Jun 3, 2026 10:30AM–12:00PM

I-008Lu Turković

Adherence to Ribociclib Treatment: Insights from Population Pharmacokinetic Simulations and Plasma Concentration Measurements

Wed, Jun 3, 2026 10:30AM–12:00PM

I-009Monir Bertayli

Use of a Clinical utility index to assess the opioid sparring effect between morphine and pregabalin and as aid in dose optimization.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-010Jacqueline Ernest

MODEL-BASED BRIDGING OF EPLONTERSEN POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS IN CHINESE HEALTHY VOLUNTEERS AND CHINESE PATIENTS WITH HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS WITH POLYNEUROPATHY SUPPORTS GLOBAL DOSING REGIMEN WITHOUT DOSE ADJUSTMENT

Wed, Jun 3, 2026 10:30AM–12:00PM

I-011Anne Kümmel

EXPOSURE-RESPONSE RELATIONSHIP OF ONCE-MONTHLY SUBCUTANEOUS OLANZAPINE (TV-44749) FOR THE CLINICAL GLOBAL IMPRESSION-SEVERITY SCALE IN PATIENTS WITH SCHIZOPHRENIA

Wed, Jun 3, 2026 10:30AM–12:00PM

I-012Haiping Xu

Population Pharmacokinetic-Pharmacodynamic Modelling of Ciprofol in Chinese Elderly Patients Undergoing Orthopedic Surgery

Wed, Jun 3, 2026 10:30AM–12:00PM

I-013Avuyonke Balfour

FOUR-SNP NAT2 GENOTYPING OUTPERFORMS TAG-SNP AND MIXTURE MODELS FOR HIGH-DOSE ISONIAZID PK

Wed, Jun 3, 2026 10:30AM–12:00PM

I-014Milena M. Boczar

PILOT STUDY AIMING TO QUANTIFY VIABLE BUT NON- OR SLOWLY REPLICATING MYCOBACTERIUM TUBERCULOSIS BACTERIA

Wed, Jun 3, 2026 10:30AM–12:00PM

I-015Harel Dahari

Modeling the Effect of Long-Acting Injectables of DAA Therapy to Reach Hepatitis C Elimination among People Who Inject Drugs

Wed, Jun 3, 2026 10:30AM–12:00PM

I-016Rasmus Henninger

Semi-mechanistic translational PK/PD modelling to support human dose selection of DNDI-6174 in cutaneous leishmaniasis

Wed, Jun 3, 2026 10:30AM–12:00PM

I-017Albin Leding

Translational prediction of pharmacologically active metabolite contribution to the relative efficacy of TBAJ-587 for early clinical development

Wed, Jun 3, 2026 10:30AM–12:00PM

I-018Leichi Liu

POPULATION PHARMACOKINETICS OF BICTEGRAVIR CO-ADMINISTERED WITH RIFAMPICIN IN ADULTS WITH HIV AND TUBERCULOSIS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-019Wen Yao Mak

INTER-LABORATORY EFFECTS ON PK/PD RELATIONSHIPS IN THE STANDARDIZED COMBINE PNEUMONIA MODEL

Wed, Jun 3, 2026 10:30AM–12:00PM

I-020Grigory Nesvijevski

MINIMAL-PBPK URINARY MODEL AND FRAMEWORK FOR INVESTIGATION OF NITROFURANTOIN, CIPROFLOXACIN AND FOSFOMYCIN EFFECT ON ESCHERICHIA COLI IN MICROFLUIDIC-BASED HOLLOW FIBER INFECTION MODEL

Wed, Jun 3, 2026 10:30AM–12:00PM

I-021Tamara Ray

PYRAZINAMIDE POPULATION PHARMACOKINETICS IN ADULTS WITH DRUG-RESISTANT TUBERCULOSIS: THE ROLE OF ALLOMETRIC SCALING

Wed, Jun 3, 2026 10:30AM–12:00PM

I-022Anh Quan Truong

A PROOF-OF-CONCEPT MECHANISTIC, SYSTEM-BASED FRAMEWORK INTEGRATING HUMAN CYTOKINES, GRANULOPOIESIS, ANTIMICROBIAL PHARMACOKINETICS, AND IN VITRO TIME-KILL EXPERIMENTS FOR HOST – PATHOGEN – ANTIMICROBIAL INTERACTIONS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-023Roland van Rensburg

POPULATION PHARMACOKINETIC MODEL OF EXTENDED-RELEASE METFORMIN IN OBESE SOUTH AFRICAN WOMEN WITH HIV RECEIVING DOLUTEGRAVIR

Wed, Jun 3, 2026 10:30AM–12:00PM

I-024Suzanne A.M. Wenker

(Val)ganciclovir against cytomegalovirus: Are we currently dosing too low?

Wed, Jun 3, 2026 10:30AM–12:00PM

I-025Arwa Alghaith

Understanding the effect of administration schedule on the efficacy of olaparib-radiation combination therapy for glioblastoma using Bayesian PKPD modelling

Wed, Jun 3, 2026 10:30AM–12:00PM

I-026Marçal Bravo i Padrós

JOINT MODELING OF TUMOR SIZE AND PROGRESSION-FREE SURVIVAL (PFS) TO SUPPORT PHASE 3 DOSE SELECTION OF ODRONEXTAMAB PLUS CHEMOTHERAPY IN PATIENTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

Wed, Jun 3, 2026 10:30AM–12:00PM

I-027

M-PROTEIN DYNAMIC METRICS TO SUPPORT EARLY DRUG DEVELOPMENT DECISIONS IN MULTIPLE MYELOMA

Wed, Jun 3, 2026 10:30AM–12:00PM

I-028Miro Julian Eigenmann

Impact of soluble BCMA on the PKPD assessment and dose selection for BCMA 4-1BBL

Wed, Jun 3, 2026 10:30AM–12:00PM

I-029Peng Man

IMMORTAL TIME BIAS IN USING IMMUNE-MEDIATED ADVERSE EVENTS AS PREDICTORS OF SURVIVAL: INSIGHTS FROM A MULTISTATE MODELING APPROACH

Wed, Jun 3, 2026 10:30AM–12:00PM

I-030Lisa Hanquet

CAR-T PERSISTENCE MODELLING: BRIDGING BIOLOGY AND DATA

Wed, Jun 3, 2026 10:30AM–12:00PM

I-031Anne Keunecke

Population PK/PD analysis of roginolisib in healthy participants using the basophil activation test to determine the PI3Kδ occupancy.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-032Brett Matzuka

Semi-Mechanistic Population PKPD model of linvoseltamab in Multiple Myeloma

Wed, Jun 3, 2026 10:30AM–12:00PM

I-033Adam Nasim

TMDD modeling for antibodies directed against soluble targets: parameter values for de novo modeling and simulation from experimental data.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-034Andrew Dwi Permana

AI-DRIVEN EARLY DETECTION OF COLORECTAL CANCER USING LONGITUDINAL AND MULTIMODAL ELECTRONIC HEALTH RECORDS IN SWEDISH PRIMARY HEALTH CARE

Wed, Jun 3, 2026 10:30AM–12:00PM

I-035Carmine Schiavone

A Scalable, Open-Source PBPK-QSP Framework for Translating the Safety and Efficacy of Bispecifics T-Cell Engager

Wed, Jun 3, 2026 10:30AM–12:00PM

I-036Rob Ter Heine

Translational modelling of pembrolizumab reveals a knowledge gap in immune checkpoint inhibitor dose development

Wed, Jun 3, 2026 10:30AM–12:00PM

I-037Isis Van herteryck

Impact of the use of different PK/PD indexes on amikacin dosing requirements in severely ill children: a population PK approach

Wed, Jun 3, 2026 10:30AM–12:00PM

I-038Chenyu Wang

Experimental and Virus-Specific Drivers of EC50 Variability in Antiviral Assays Evaluated Using Mathematical Modeling

Wed, Jun 3, 2026 10:30AM–12:00PM

I-039Miguel Allo

PHARMACOKINETIC–PHARMACODYNAMIC MODELING AND IN VIVO DRUG RELEASE EVALUATION OF CARVEDILOL CONTROLLED-RELEASE FORMULATIONS IN SPONTANEOUSLY HYPERTENSIVE RATS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-040Pavel Balazki

Automating Scalable End-to-End MIDD Workflows: A Database-Driven Framework for Modular PBPK-QSP Assembly using the Open Systems Pharmacology Suite

Wed, Jun 3, 2026 10:30AM–12:00PM

I-041Yinru Chen

Defining site-relevant PK/PD targets for nemonoxacin dosing in Streptococcus pneumoniae-associated community-acquired pneumonia through a translational PK/PD approach

Wed, Jun 3, 2026 10:30AM–12:00PM

I-042Anthéa Deschamps

Mechanistic biomarker model of serum creatinine in critically ill patients

Wed, Jun 3, 2026 10:30AM–12:00PM

I-043Maud Hennion

Translational Modeling Based on a Semi-Mechanistic Target-Mediated Drug Disposition (TMDD) Approach

Wed, Jun 3, 2026 10:30AM–12:00PM

I-044Hyeseon Jeon

Meta-analytic prior integration reduces prior dependency in sparse TDM-based PopPK modeling: Application to infliximab in pediatric IBD

Wed, Jun 3, 2026 10:30AM–12:00PM

I-045Jeroen Koomen

MODEL-INFORMED APPROACHES FOR PEDIATRIC TYPE 2 DIABETES EVIDENCE GENERATION: INSIGHTS FROM A MODEL-BASED LONGITUDINAL HBA1C META-ANALYSIS FROM EMA MARKETING AUTHORIZATION APPLICATIONS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-046Min Li

Integrated Pharmacokinetics–Receptor Occupancy Modeling of EVER001 to Guide Clinical Efficacious Dose Projection for Primary Membranous Nephropathy

Wed, Jun 3, 2026 10:30AM–12:00PM

I-047Oleg Milberg

MECHANISTIC TARGET-MEDIATED POPULATION PK/PD MODELLING OF REGN7508Cat ACROSS HEALTHY VOLUNTEERS AND ORTHOPEDIC SURGERY POPULATIONS WITH TRANSLATIONAL EVALUATION IN PATIENTS WITH PICCS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-048Catherine Ollagnier

TRANSLATIONAL MODELING PLATFORM TO CONNECT IN VITRO POTENCY TO
PRECLINICAL WEIGHT LOSS FOR GLP-1 RECEPTOR AGONISTS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-049Zvonimir Petric

From Modeling and Simulation to Personalized Dosing Decisions in IBD: Moving Beyond the Arbitrarily (Pre)Defined Therapeutic Windows and One-Size-Fits-All Dosing Paradigm

Wed, Jun 3, 2026 10:30AM–12:00PM

I-050Stephan Schaller

A Modular PBPK-QSP Platform for Renal–Cardiovascular Pharmacology: Simulating RAAS-Targeted Therapies and Drug-Induced Kidney Injury

Wed, Jun 3, 2026 10:30AM–12:00PM

I-051KILELA Songela Reagan

APPLICATION OF PHARMACOKINETIC MODELING AND SIMULATION IN THE BIOEQUIVALENCE ASSESSMENT OF GENERIC DRUGS: THE CASE OF LUMEFANTRINE

Wed, Jun 3, 2026 10:30AM–12:00PM

I-052Pieter Van Brantegem

Global sensitivity analysis of a mechanistic PK/PD model for T cell engager–mediated peripheral B‑cell depletion

Wed, Jun 3, 2026 10:30AM–12:00PM

I-053Thi Ngoc Anh Vu

Beyond the Michaelis–Menten: A Modified Enzyme Kinetics Framework for Bottom-Up PBPK Modeling and Its Implementation in the Simcyp® Platform

Wed, Jun 3, 2026 10:30AM–12:00PM

I-054Michael Williams

Population K-PD modeling incorporating CFB to mediate suppression of CAP activity informs AZD6912 early clinical development

Wed, Jun 3, 2026 10:30AM–12:00PM

I-055Tatiana Zasedateleva

PBPK/PD MODELING TO ASSESS ANTIBODY-INDUCED IMMUNE CELL DEPLETION AND PD-DEPENDENT CLEARANCE IN SYSTEMIC LUPUS ERYTHEMATOSUS AND RHEUMATOID ARTHRITIS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-056Julie Dudasova

A logistic regression framework for predicting time‑varying vaccine efficacy using longitudinal immunogenicity data: a dengue vaccine case study

Wed, Jun 3, 2026 10:30AM–12:00PM

I-057Patrick Kofod Mogensen

SIMULATION AND ESTIMATION OF CORRELATED NON-GAUSSIAN RANDOM EFFECTS IN PUMAS USING COPULAS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-058Renwei Zhang

Missing data imputation for aggregate covariates of patient characteristics in model-based meta-analysis

Wed, Jun 3, 2026 10:30AM–12:00PM

I-059David Müller-Widmann

MONTE CARLO EXPECTATION-MAXIMIZATION IN PUMAS: LEVERAGING SUFFICIENT STATISTICS FOR FLEXIBLE PHARMACOMETRIC ANALYSIS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-060Pauline Bogdanovich

BAYESIAN QUANTIFICATION OF BIAS AND UNCERTAINTY IN SIMCYP V19 PREDICTIONS OF DRUG-DRUG INTERACTIONS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-061Maria Kalliga

Cross-tissue evaluation of a proteomics-derived ppm-to-nM conversion for target expression inputs to antibody PBPK/TMDD models

Wed, Jun 3, 2026 10:30AM–12:00PM

I-063Yixuan Cao

Physiologically-based pharmacokinetic model to predict loading dose polymyxin B exposure in critically ill patients with sepsis

Wed, Jun 3, 2026 10:30AM–12:00PM

I-064Antoine Croxo

MODEL-BASED TESTING TO ASSESS CMAX BIOEQUIVALENCE IN HIGHLY VARIABLE DRUGS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-065Ricardo Diaz De Leon Ortega

USING PBPK MODELLING TO IDENTIFY PHYSIOLOGICAL CHANGES INDUCED BY CLF065, A GLP 2 RECEPTOR AGONIST, ON THE PHARMACOKINETICS OF ACYCLOVIR AND TO PREDICT POTENTIAL DRUG–DRUG INTERACTIONS WITH OTHER COMPOUNDS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-066Meng Gu

A Whole-Body PBPK Model to Quantify Organ-Specific Biodistribution and Systemic Clearance of Bacteriophages

Wed, Jun 3, 2026 10:30AM–12:00PM

I-067Masoud Jamei

Assessing Cross-Version Simcyp Simulator Prediction Performance Using a Bioequivalence Framework to Support EMA Qualification

Wed, Jun 3, 2026 10:30AM–12:00PM

I-068Cong Liu

Integrating Endogenous Ligand Competition into a Mechanistic Whole-Body PBPK Model of Therapeutic Monoclonal Antibodies

Wed, Jun 3, 2026 10:30AM–12:00PM

I-069Neville Mwesigwa

Prediction of Hydroxyurea Pharmacokinetics and Dose Adjustment in Children with Mild, Moderate, and Severe Renal Impairment Using Physiologically Based Pharmacokinetic Modeling

Wed, Jun 3, 2026 10:00AM–12:00AM

I-070Pascale Rietveld

A physiologically-based pharmacokinetic model for intraperitoneal irinotecan to evaluate the impact of UGT1A1 variability on SN-38 exposure

Wed, Jun 3, 2026 10:30AM–12:00PM

I-071Oleg Stepanov

AI AUTOMATION MEETS PBPK: AN R SHINY APPLICATION WITH LARGE LANGUAGE MODEL INTEGRATION FOR EFFICIENT PHYSIOLOGICALLY BASED PHARMACOKINETIC MODEL REPORTING

Wed, Jun 3, 2026 10:30AM–12:00PM

I-072Paul Vrenken

Food effect prediction of high permeability/low solubility compound, formulated as an amorphous solid dispersion (ASD) using an Open Systems Pharmacology (OSP) PBBM approach

Wed, Jun 3, 2026 10:30AM–12:00PM

I-073Aole Zheng

AN OCULAR EXPOSURE PREDICTION FOR TOPICAL ATROPINE IN HUMANS USING PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING

Wed, Jun 3, 2026 10:30AM–12:00PM

I-074Kamau Pierre

TOWARDS AN INTEGRATED METABOLISM QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL FOR SUPPORTING A PIPELINE OF OBESITY THERAPEUTICS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-075Kirill Zhudenkov

Population Pharmacokinetics of Olokizumab in Healthy Volunteers and Rheumatoid Arthritis Subjects

Wed, Jun 3, 2026 10:30AM–12:00PM

I-076Estelle Chasseloup

Regulatory-Informed Model Refinement: From Adult-Only to Adult–Pediatric PopPK Integration and its implications

Wed, Jun 3, 2026 10:30AM–12:00PM

I-077Farina Hellmann

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

Wed, Jun 3, 2026 10:30AM–12:00PM

I-078Jakob Kolar

EVALUATION OF MODEL SELECTION AND AVERAGING ALGORITHMS FOR MODEL-INFORMED PRECISION DOSING OF GENTAMICIN IN NEONATES

Wed, Jun 3, 2026 10:30AM–12:00PM

I-079Ana Rodríguez-Báez

NORMALIZATION TO BODY WEIGHT IN PAEDIATRIC PHARMACOKINETICS: IMPACT ON CLEARANCE SCALING

Wed, Jun 3, 2026 10:30AM–12:00PM

I-080Jennie van Dyk

Simulation-based guideline implementation of weight-banded dosing strategies for childhood leprosy

Wed, Jun 3, 2026 10:30AM–12:00PM

I-081Simona Catozzi

A framework for drug safety assessment based on target affinity, drug exposure and plasma protein binding – dissecting FDA drug-induced cardiotoxicity data from a translational pharmacology perspective

Wed, Jun 3, 2026 10:00AM–12:00AM

I-082Seyeon Hwang

Comparative Acute Kidney Injury Risk Across Antibiotics Commonly Used for Severe Infections in Hospitalized Patients: A Time-Varying Causal Analysis

Wed, Jun 3, 2026 10:30AM–12:00PM

I-083Ke Szeto

MODEL-INFORMED COMPARATIVE PHARMACOKINETIC AND PHARMACOLOGIC PROFILING HIGHLIGHT JAK1 SELECTIVITY OF POVORCITINIB

Wed, Jun 3, 2026 10:30AM–12:00PM

I-084Racym Berrah

TOWARD AUTONOMOUS PHARMACOMETRICS: A MULTI AGENT FRAMEWORK FOR STRUCTURE DISCOVERY, COVARIATE SELECTION AND GRAY-BOX MODELING

Wed, Jun 3, 2026 10:30AM–12:00PM

I-085Ilaria Gaiffi

MODEL-INFORMED REINFORCEMENT LEARNING FOR PRECISION DOSING OF CARBOPLATIN

Wed, Jun 3, 2026 10:30AM–12:00PM

I-086Marian Klose

DIRECT AND HYBRID MACHINE LEARNING APPROACHES DO NOT OUTPERFORM NLME-BASED FULL BAYESIAN FORECASTING FOR EARLY IDENTIFICATION OF DELAYED METHOTREXATE ELIMINATION

Wed, Jun 3, 2026 10:30AM–12:00PM

I-087Thi Nga Mai

EXPLAINABLE DEEP WEIBULL SURVIVAL MODELING FOR PREDICTING TIME TO COGNITIVE IMPAIRMENT IN OLDER ADULTS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-088Emily Nieves

Automating Literature-Based Workflows with Delineate: From Evidence Synthesis to Model Reuse

Wed, Jun 3, 2026 10:00AM–12:00AM

I-090TARJINDER SAHOTA

The hybrid AI/ML – Pharmacometrics
Communications Cheat Sheet

Wed, Jun 3, 2026 10:30AM–12:00PM

I-091Mikael Sunnåker

Assessment of neural ODEs for modeling of longitudinal adverse events data and predictions of new treatment regimens

Wed, Jun 3, 2026 10:30AM–12:00PM

I-092Elisa Calvier

Accelerating Gold Standard Evolution in Pharmacometrics: A Framework for Cross-Study Benchmarking of Covariate Modeling Methods

Wed, Jun 3, 2026 10:30AM–12:00PM

I-093Niklas Hartung

Mechanistic lumping of linear PBPK models

Wed, Jun 3, 2026 10:30AM–12:00PM

I-094Niklas Korsbo

Post-hoc model joining with Normalizing Flows for efficient and scalable multi-endpoint PKPD

Wed, Jun 3, 2026 10:30AM–12:00PM

I-095Peng Man

Apparent Time Dependence and Rethinking Random Effect under Single Time-to-Event Models

Wed, Jun 3, 2026 10:30AM–12:00PM

I-096Enrico Grisan

CVAE–LASSO: INTEGRATED L1-REGULARIZED COVARIATE SELECTION WITHIN A CONDITIONAL LATENT FRAMEWORK FOR POPULATION PHARMACOKINETIC MODELLING

Wed, Jun 3, 2026 10:30AM–12:00PM

I-097Mark Sale

QPC: Predicting Human Interpretation of VPC Plots

Wed, Jun 3, 2026 10:30AM–12:00PM

I-098Sabine Stübler

EVALUATION OF AUTOMATIC MODEL DEVELOPMENT TOOLS PYDARWIN AND PHARMPY USING CLINICAL POPULATION PK DATA

Wed, Jun 3, 2026 10:30AM–12:00PM

I-099Abraham Vaquero Castro

A Generative AI approach for reconstructing synthetic data cohorts for MBMA.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-100Jamilah Alnahdi

Model-Informed Drug Development at Sِaudi FDA: Approaches, Applications, and Regulatory Impact

Wed, Jun 3, 2026 10:00AM–12:00AM

I-101Stephanie Kollmann

monolixSuiteTFL: AN R PACKAGE FOR AUTOMATED TABLES, FIGURES AND LISTINGS FROM MONOLIXSUITE PROJECTS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-102Victor Sokolov

SimuRg: an R wrapper package for an AI-based pharmacometrics ecosystem

Wed, Jun 3, 2026 10:30AM–12:00PM

I-103Carla Troisi

STREAMLINED OPEN-SOURCE PBPK DDI ASSESSMENTS USING THE OSP SUITE WITH R-BASED esqlabsR/ESQapp WORKFLOWS

Wed, Jun 3, 2026 10:30AM–12:00PM

I-104Lisa Wellin

POPULATION PHARMACOKINETIC MODELLING TO SUPPORT BIOEQUIVALENCE ASSESSMENT OF GENERIC DRUGS: AN ILLUSTRATIVE SIMULATION STUDY USING AMODIAQUINE.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-105Han Zheng

COMPARISON OF MASPECTRA AND NONMEM FOR POPULATION PHARMACOKINETIC MODELING: AN ABSK-011 (IRPAGRATINIB) CASE STUDY

Wed, Jun 3, 2026 10:00AM–12:00AM

I-106Stefano Grosdani

Translational pharmacology and optimisation of a first-time-in-children protocol for the evaluation of the safety, tolerability, pharmacokinetics and preliminary efficacy of BGA002 in refractory MYCN-altered tumours.

Wed, Jun 3, 2026 10:30AM–12:00PM

I-107France Mentré

Design Evaluation and Optimisation with Discrete Covariates and Inter-Occasion Variability in Nonlinear Mixed Effects Models: The R Package PFIM 7.1

Wed, Jun 3, 2026 10:30AM–12:00PM

I-108Keqi Shi

Evaluation of the Impact of Machine-learning-informed Optimal Study Design on the Identifiability of Key Pharmacokinetic Parameters in Preclinical Intravenous Rat Pharmacokinetic Studies

Wed, Jun 3, 2026 10:30AM–12:00PM

I-109Daria Zhuravleva

APPLICATION OF CONTINUOUS-CATEGORICAL IRT MODELLING TO ENHANCE STATISTICAL POWER IN N-OF-1 TRIALS: SIMULATION-BASED EVALUATION

Wed, Jun 3, 2026 10:30AM–12:00PM

IV-037Chen Wang

PREDICTING PROGRESSION-FREE SURVIVAL FOR ABSK-011 (IRPAGRATINIB) IN ADVANCED FGF19+ HCC PATIENTS VIA JOINT MODELING OF TUMOR GROWTH DYNAMICS

Wed, Jun 3, 2026 10:30AM–12:00PM