Abstracts

Executing >100,000 Model Fits: Scalable and Reproducible Pharmacometric Workflows Using NLME/RsNLME

Thursday 7 May, 2026

Objectives Pharmacometric analyses increasingly rely on complex nonlinear mixed-effects (NLME) modeling, large-scale simulations, and simulation-based inference to support study design,…

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

Thursday 7 May, 2026

Introduction/Objectives: Automatic model development (AMD) aims to accelerate population PK (popPK) model building and enhance structural robustness by replacing subjective…

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Population pharmacokinetics of aprocitentan and dose rationale for paediatric patients aged from 2 to less than 18 years affected by pulmonary arterial hypertension.

Thursday 7 May, 2026

Objectives: Pulmonary arterial hypertension (PAH) is defined by elevated pulmonary vascular resistance, leading to right heart failure and ultimately death…

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New methods based on the Fisher Information Matrix for evaluation and optimisation of designs testing relevance of covariates in pharmacometrics

Thursday 7 May, 2026

Objectives One aim of pharmacometrics is to explain inter-individual variability (IIV) through covariate identification [1]. Covariate effects are assessed through…

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Population pharmacokinetics and exposure-response analysis of tideglusib in children and adolescents with congenital myotonic dystrophy type 1

Thursday 7 May, 2026

Objectives. Tideglusib is an orally administered, brain-penetrant, irreversible inhibitor of glycogen synthase kinase-3β (GSK-3β), a serine/threonine kinase involved in multiple…

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Semi-Mechanistic Population PKPD model of linvoseltamab in Multiple Myeloma

Thursday 7 May, 2026

Introduction: Linvoseltamab is a BCMAxCD3 bispecific antibody approved for triple-class exposed relapsed/refractory (RR) multiple myeloma (MM) after 3 therapies (EU)…

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THE CRITICAL ROLE OF GASTRIC REACIDIFICATION IN PHYSIOLOGICALLY-BASED PHARMACOKINETIC (PBPK) MODELS INVESTIGATING FOOD EFFECT: A CASE STUDY WITH PICTILISIB

Thursday 7 May, 2026

Introduction Gastrointestinal tract physiology is influenced by prandial state, with characteristic differences in gastric pH, gastric emptying time, bile salt…

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ConstrainNODE-PK: Constrained neural impulse-response population PK for trial simulation and regimen transfer without compartmental selection

Thursday 7 May, 2026

Objectives: Machine-learning (ML) models are increasingly proposed as rapid, automated alternatives to nonlinear mixed-effects (NLME) pharmacokinetic (PK) modelling. However, many…

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Regularized estimation in high-dimensional mechanistic models: application to vaccine development

Thursday 7 May, 2026

Objectives : Mechanistic models are widely used to describe and explain biological processes over time [1]. However, they typically rely…

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

Thursday 7 May, 2026

Background Pharmacometric time-to-event (TTE) analysis commonly applies parametric survival models and often assumes a homogeneous population hazard after covariate effects…

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