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
Introduction/Objectives: Automatic model development (AMD) aims to accelerate population PK (popPK) model building and enhance structural robustness by replacing subjective…
Read morePopulation pharmacokinetics of aprocitentan and dose rationale for paediatric patients aged from 2 to less than 18 years affected by pulmonary arterial hypertension.
Objectives: Pulmonary arterial hypertension (PAH) is defined by elevated pulmonary vascular resistance, leading to right heart failure and ultimately death…
Read moreNew methods based on the Fisher Information Matrix for evaluation and optimisation of designs testing relevance of covariates in pharmacometrics
Objectives One aim of pharmacometrics is to explain inter-individual variability (IIV) through covariate identification [1]. Covariate effects are assessed through…
Read morePopulation pharmacokinetics and exposure-response analysis of tideglusib in children and adolescents with congenital myotonic dystrophy type 1
Objectives. Tideglusib is an orally administered, brain-penetrant, irreversible inhibitor of glycogen synthase kinase-3β (GSK-3β), a serine/threonine kinase involved in multiple…
Read moreSemi-Mechanistic Population PKPD model of linvoseltamab in Multiple Myeloma
Introduction: Linvoseltamab is a BCMAxCD3 bispecific antibody approved for triple-class exposed relapsed/refractory (RR) multiple myeloma (MM) after 3 therapies (EU)…
Read moreTHE CRITICAL ROLE OF GASTRIC REACIDIFICATION IN PHYSIOLOGICALLY-BASED PHARMACOKINETIC (PBPK) MODELS INVESTIGATING FOOD EFFECT: A CASE STUDY WITH PICTILISIB
Introduction Gastrointestinal tract physiology is influenced by prandial state, with characteristic differences in gastric pH, gastric emptying time, bile salt…
Read moreConstrainNODE-PK: Constrained neural impulse-response population PK for trial simulation and regimen transfer without compartmental selection
Objectives: Machine-learning (ML) models are increasingly proposed as rapid, automated alternatives to nonlinear mixed-effects (NLME) pharmacokinetic (PK) modelling. However, many…
Read moreRegularized estimation in high-dimensional mechanistic models: application to vaccine development
Objectives : Mechanistic models are widely used to describe and explain biological processes over time [1]. However, they typically rely…
Read moreApparent Time Dependence and Rethinking Random Effect under Single Time-to-Event Models
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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