Abstracts

Insights into Preclinical and Translational Challenges in Oncology Model-Informed Drug Development

Monday 11 May, 2026

This talk addresses key preclinical and early translational challenges in oncology model-informed drug development. It explores emerging immunomodulatory therapies,alongside the…

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Opemalirsen antisense oligonucleotide targeting the APOL1 mRNA provide dose-dependent APOL1 reduction in plasma

Thursday 7 May, 2026

Objectives APOL1-mediated kidney disease (AMKD) is associated with toxic gain of function variants in people of African ancestry with the…

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DEVELOPMENT OF AN INTERSPECIES-SCALED PBPK MODEL AND STRUCTURAL PK–PD FRAMEWORK FOR ABROCITINIB

Thursday 7 May, 2026

Introduction / Objective Abrocitinib is an oral selective Janus kinase 1 (JAK1) inhibitor approved for the treatment of moderate-to-severe atopic…

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Opemalirsen antisense oligonucleotide targeting the APOL1 mRNA does not prolong the QTc interval.

Thursday 7 May, 2026

Objectives Opemalirsen (previously known as AZD2373) is an antisense oligonucleotide (ASO) targeting the APOL1 mRNA. It is currently explored as…

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Quantitative Predictive Check (QPC): A Scalar Framework for Objective and Optimization-Ready VPC Evaluation

Thursday 7 May, 2026

Introduction: Model evaluation in pharmacometrics relies on multiple criteria, including likelihood-based statistics, parameter precision, plausibility of covariate effects, and graphical…

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Application of a Simulation-Based Diagnostics for Survival Evaluation in Joint Models

Thursday 7 May, 2026

Introduction: Joint modeling methodology that integrates longitudinal biomarkers and time-to-event outcomes has become an essential component of pharmacometric analyses in…

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INTEGRATED POPULATION PHARMACOKINETIC AND EXPOSURE-RESPONSE MODELING OF ENLICITIDE IN HYPERCHOLESTEROLEMIA PATIENTS SUPPORTS CLINICAL DOSE RECOMMENDATION ACROSS PATIENT SUBGROUPS

Thursday 7 May, 2026

Introduction: Despite the well-established cardiovascular benefit of LDL-cholesterol (LDL-C) lowering, real-world use of PCSK9-targeted therapies remains limited, in part due…

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

Thursday 7 May, 2026

Title: Model-Informed Drug Development at Sِaudi FDA: Approaches, Applications, and Regulatory Impact Author: Alanood Alkhaldi (1), Jamilah Alnahdi(1), Abdullah Alsultan(2),…

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Is regrowth of Mycobacterium tuberculosis always a sign of phenotypical resistance? A model-based approach to interpret drug instability and the implications for potency estimation in time-kill assays.

Thursday 7 May, 2026

Introduction:The observed regrowth of Mycobacterium tuberculosis (Mtb) in vitro is often attributed to the emergence of phenotypical resistance or relapse-associated…

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Machine learning for covariate imputation – application in a real-world scenario

Thursday 7 May, 2026

Objective: Population pharmacokinetic (PopPK) models describe the changes in drug concentration across diverse patient populations, leveraging covariate effects using a…

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