Abstracts

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

Thursday 7 May, 2026

Introduction: The efficacy of a new medicinal drug product indicated for the treatment or prevention of Type 2 Diabetes Mellitus…

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Combining aggregate data and individual patient/subject data in model-based meta-analysis: An illustrative case study of tofacitinib in rheumatoid arthritis patients

Thursday 7 May, 2026

Introduction: Model-based meta-analysis (MBMA) is widely used to integrate aggregate data (AD) from randomized controlled trials (RCTs) within a pharmacologically…

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Mechanistic lumping of linear PBPK models

Thursday 7 May, 2026

OBJECTIVES Physiologically-based pharmacokinetic (PBPK) models predict blood and tissue concentrations through a complex physiological parametrization and compartmentalization. Proper lumping allows…

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A FIT-FOR-PURPOSE PHYSIOLOGICALLY BASED PHARMACOKINETIC APPROACH FOR INTRANASAL ANALGESICS: APPLICATION TO KETAMINE AND FENTANYL ANALOGS

Thursday 7 May, 2026

Introduction/Objectives: Intranasal delivery is widely used for rapidly acting analgesics in emergency and perioperative settings. Lipophilic weak bases such as…

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THE TRANSLATIONAL ZEBRAFISH LARVAE FRAMEWORK ACCURATELY PREDICTS BEDAQUILINE’S CLINICAL EARLY BACTERICIDAL ACTIVITY AGAINST TUBERCULOSIS

Thursday 7 May, 2026

Introduction: Tuberculosis (TB) is a leading cause of death worldwide[1]. Translational pharmacometrics is vital to accelerate the development of novel…

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USING PKPD MODELLING AND EXTERNAL EVIDENCE TO INFORM PAEDIATRIC EXTRAPOLATION: A CASE STUDY

Thursday 7 May, 2026

Objectives: INVENTS project (https://invents-he.eu/) aims to assess and improve modelling and simulation approaches and their regulatory acceptance to expedite drug…

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

Thursday 7 May, 2026

As part of the qualification of the Simcyp Simulator V19 by the European Medicine Agency (EMA) in 2025, a statistical…

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Pharmacometric Evaluation of Patient-Reported Symptom Burden in Oral Anticancer Therapy With Axitinib and Cabozantinib Using Minimal Continuous-time Markov Models

Thursday 7 May, 2026

Objective: Adverse drug events (ADEs) are a substantial burden for patients undergoing antitumor therapy and, in the worst case, may…

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

Thursday 7 May, 2026

Objectives: Polymyxin B (PMB) is among the few antibiotics retaining activity against carbapenem-resistant Gram-negative pathogens [1], yet its pharmacokinetics (PK)…

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Mechanistic Modelling of SARS-CoV-2 Viral Dynamics and Antiviral Effects to Link Viral Exposure with Clinical Outcomes

Thursday 7 May, 2026

Introduction: To evaluate antiviral effectiveness, the PANORAMIC trial, a large open-label platform study, was conducted in outpatients at increased risk…

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