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
Introduction: Model-based meta-analysis (MBMA) is widely used to integrate aggregate data (AD) from randomized controlled trials (RCTs) within a pharmacologically…
Read moreMechanistic lumping of linear PBPK models
OBJECTIVES Physiologically-based pharmacokinetic (PBPK) models predict blood and tissue concentrations through a complex physiological parametrization and compartmentalization. Proper lumping allows…
Read moreA FIT-FOR-PURPOSE PHYSIOLOGICALLY BASED PHARMACOKINETIC APPROACH FOR INTRANASAL ANALGESICS: APPLICATION TO KETAMINE AND FENTANYL ANALOGS
Introduction/Objectives: Intranasal delivery is widely used for rapidly acting analgesics in emergency and perioperative settings. Lipophilic weak bases such as…
Read moreTHE TRANSLATIONAL ZEBRAFISH LARVAE FRAMEWORK ACCURATELY PREDICTS BEDAQUILINE’S CLINICAL EARLY BACTERICIDAL ACTIVITY AGAINST TUBERCULOSIS
Introduction: Tuberculosis (TB) is a leading cause of death worldwide[1]. Translational pharmacometrics is vital to accelerate the development of novel…
Read moreUSING PKPD MODELLING AND EXTERNAL EVIDENCE TO INFORM PAEDIATRIC EXTRAPOLATION: A CASE STUDY
Objectives: INVENTS project (https://invents-he.eu/) aims to assess and improve modelling and simulation approaches and their regulatory acceptance to expedite drug…
Read moreBAYESIAN QUANTIFICATION OF BIAS AND UNCERTAINTY IN SIMCYP V19 PREDICTIONS OF DRUG-DRUG INTERACTIONS
As part of the qualification of the Simcyp Simulator V19 by the European Medicine Agency (EMA) in 2025, a statistical…
Read morePharmacometric Evaluation of Patient-Reported Symptom Burden in Oral Anticancer Therapy With Axitinib and Cabozantinib Using Minimal Continuous-time Markov Models
Objective: Adverse drug events (ADEs) are a substantial burden for patients undergoing antitumor therapy and, in the worst case, may…
Read morePhysiologically-based pharmacokinetic model to predict loading dose polymyxin B exposure in critically ill patients with sepsis
Objectives: Polymyxin B (PMB) is among the few antibiotics retaining activity against carbapenem-resistant Gram-negative pathogens [1], yet its pharmacokinetics (PK)…
Read moreMechanistic Modelling of SARS-CoV-2 Viral Dynamics and Antiviral Effects to Link Viral Exposure with Clinical Outcomes
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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