Introduction/Objectives Chemotherapy-induced neutropenia remains a significant dose-limiting toxicity, and granulocyte colony-stimulating factor (G-CSF) prophylaxis represents a cornerstone of supportive care…
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Translating pharmacometric modeling into global clinical practice: lessons learned from developing a scalable clinical decision support system for pediatric thyroid care
Objectives: Can pharmacometric (PMX) modeling support individualized dose optimization in pediatric thyroid diseases, where inter-individual variability, developmental changes, and heterogeneous…
Read moremonolixSuiteTFL: AN R PACKAGE FOR AUTOMATED TABLES, FIGURES AND LISTINGS FROM MONOLIXSUITE PROJECTS
INTRODUCTION Clinical reporting of Tables, Figures and Listings (TFLs) is often time-consuming and error-prone due to repetitive post-processing and formatting…
Read moreNew tests for trials evaluating disease-modifying treatment in very few patients using longitudinal data in Autosomal Recessive Cerebellar Ataxias
Objectives: Autosomal Recessive Cerebellar Ataxias (ARCAs) are ultra-rare, progressive neurodegenerative disorders that primarily affect the cerebellum but also cause multi-systemic…
Read moreA MECHANISM-BASED PARSIMONIOUS CAR-T CELL POPULATION PK MODEL AND ITS VALIDATION VIA EXTENSION TO A POPULATION PK-TUMOR SIZE DYNAMICS MODEL: CASE STUDY WITH AXICABTAGENE CILOLEUCEL AND BREXUCABTAGENE AUTOLEUCEL
Objectives: Chimeric antigen receptor (CAR)-T cell therapies display pharmacokinetics (PK) characterized by distribution, expansion, and elimination. These PK are often…
Read moreMethodological Considerations in Model-Based Meta-Analysis (MBMA): Concepts, Applications, and Implementation
This tutorial aims to expound on methodological aspects typically encountered when performing model-based meta-analyses (MBMA). This includes how to handle…
Read morePopulation Pharmacokinetic Model of Tebipenem (TBP) in Blood and Plasma after Oral Administration of Tebipenem Pivoxil (TBP-PI) in Adult Participants.
Introduction: Tebipenem pivoxil (TBP-PI) is an orally bioavailable carbapenem prodrug that is rapidly converted in vivo to the active moiety,…
Read morePharmacokinetic and pharmacodynamics of BTZ-043 in patients with pulmonary tuberculosis
Objectives BTZ-043, a drug candidate currently under investigation for treatment of tuberculosis (TB), inhibits cell wall synthesis of mycobacteria by…
Read moreHandling Hysteresis in Concentration–QTc Analysis: A PK/PD Effect-Compartment Approach Illustrated with Vanoxerine
Introduction: The assessment of proarrhythmic risk via the analysis of QT interval prolongation is an integral part of drug development. Since…
Read moreModel-based approach to optimizing antibiotic therapy for central nervous system infections: integrating blood-brain barrier permeability, cerebrospinal fluid hydrodynamics, and site-specific drug exposure
Objectives: Central nervous system (CNS) infections such as meningitis, ventriculitis, and encephalitis occur across physiologically distinct compartments where antibiotic distribution…
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