Introduction:Â First-in-human (FiH) studies require a range of doses extrapolated from pharmacokinetic (PK) animal studies combined with safety assessments. Subtherapeutic doses…
Read morePoster: Methodology - New Modelling Approaches
Using Generative AI Variational Autoencoders with Neural Ordinary Differential Equations to Improve Nonlinear Mixed-Effects Pharmacometric Modeling
Objectives Pharmacometrics (PMX) modeling is essential for optimizing drug therapy and drug development. Nonlinear Mixed-Effects (NLME) modeling is used to…
Read moreIMPROVING CLINICAL DATA HARMONIZATION FOR POPULATION APPROACHES USING GRAPH DATABASES
Introduction/Objectives. Population approaches typically rely on relational, tabular datasets as the core structure for storing and transforming clinical information prior…
Read moreA NOVEL MATHEMATICAL FRAMEWORK TO PREDICT IN VIVO BISPECIFIC GTX-B001 BINDING IN SKIN AND TRANSLATION TO HUMANS
INTRODUCTION: GTX-B001 is a humanized bispecific antibody designed to selectively target and inhibit mast cells by binding to c-Kit and…
Read moreEVALUATION 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 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…
Read moreGenerating Realistic Virtual Populations for In Silico Clinical Trials to Inform Phase 3 Trial Design: Application to Isatuximab in Relapsed Refractory Multiple Myeloma
Introduction: Drug development in oncology faces high failure rates and significant costs, due to methodological and operational challenges. Modeling and…
Read moreModel Averaging for Individual Predictions in Joint Nonlinear Mixed-Effects Models
Introduction Nonlinear mixed-effects models (NLMEMs) are widely used in model-informed precision dosing (MIPD), particularly in pharmacokinetic–pharmacodynamic (PK/PD) analyses in which…
Read moreBOUNDED INTEGER MODELING OF NEUROPATHY, QUALITY OF LIFE AND ACUTE ADVERSE EVENT SCALES IN PATIENTS WITH COLORECTAL CANCER
Introduction: Oxaliplatin-based chemotherapy is vital for patients with colorectal cancer [1]. However, the treatment can cause serious side effects such…
Read moreA framework for nlmixr2auto: an open-source R package on CRAN for automated population pharmacokinetic modelling
Introduction/Objectives. Population pharmacokinetic modelling (PopPK) is an essential tool in drug development and clinical practice, supporting dose optimisation and individualised…
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