Thursday 7 May, 2026
Introduction/objectives: High-dose methotrexate (HDMTX) is integral to pediatric acute lymphoblastic leukemia (ALL) consolidation therapy but exhibits high variability in exposure…
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Advancing sample size justifications in confirmatory paediatric exposure-matching trials submitted to regulatory authorities: a benchmarking analysis and novel methodological framework.
Thursday 7 May, 2026
Introduction: Generation of evidence in the paediatric population is often hampered by difficulties in conducting clinical trials [1]. Extrapolation of…
Read morePopulation pharmacokinetic modeling to characterize the exposure of LASSBio-1736 in rats
Thursday 7 May, 2026
Background and objectives: Leishmaniasis is a zoonotic disease caused by the intracellular protozoan Leishmania sp., transmitted by phlebotomine vectors, affecting…
Read morePopulation K-PD modeling incorporating CFB to mediate suppression of CAP activity informs AZD6912 early clinical development
Thursday 7 May, 2026
Objectives AZD6912 is a GalNAc-conjugated double-stranded small interfering RNA (siRNA) [1] which has been administered in a first-in-human dose escalation…
Read moreA Generic IgG Pharmacokinetic Model Applied to Adalimumab and Extended to Capture Anti-Drug Antibody effects
Thursday 7 May, 2026
Introduction: Therapeutic monoclonal antibodies (mAb) share a high similarity in physiological and pharmacokinetic (PK) properties, suggesting that an underlying generic…
Read morePOPULATION PHARMACOKINETICS AND PHARMACOGENOMICS OF ETHAMBUTOL IN AN AFRICAN COHORT WITH DRUG RESISTANT PULMONARY TUBERCULOSIS
Thursday 7 May, 2026
Objectives: Ethambutol is a first-line antitubercular drug included in World Health Organization recommended regimen for tuberculosis (TB) and is also…
Read morePOPULATION PHARMACOKINETICS AND EXPOSURE–RESPONSE MODELING SUPPORTS OPTIMIZED USTEKINUMAB INDUCTION DOSING IN CHRONIC POUCHITIS
Thursday 7 May, 2026
Introduction: Pouchitis is a frequent and clinically significant complication following restorative proctocolectomy with ileal pouch–anal anastomosis in patients with ulcerative…
Read moreIntegrating Endogenous Ligand Competition into a Mechanistic Whole-Body PBPK Model of Therapeutic Monoclonal Antibodies
Thursday 7 May, 2026
Objective Monoclonal antibodies (mAbs) frequently exert their pharmacological effects by competing with endogenous ligands for binding to shared targets, thereby…
Read morePhysiologically Based Pharmacokinetic Modeling of Cefotaxime to Inform Pediatric Dosing in Renal Impairment
Thursday 7 May, 2026
Introduction: Cefotaxime is a broad spectrum, third-generation cephalosporin antibiotic prescribed for the treatment of severe infections in pediatrics (1). Renal…
Read morePopulation Pharmacokinetics/Pharmacodynamics (PK/PD) and Time-to-Event (TTE) Analysis of Major Bleeding for Rivaroxaban-Treated Patients with Atrial Fibrillation: Assessing the Influence of Heart Failure through Left- and Right-Ventricular Performance Markers
Thursday 7 May, 2026
OBJECTIVES: Rivaroxaban is a cornerstone of stroke prevention in atrial fibrillation (AF), yet major bleeding remains a significant clinical concern…
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