Thursday 16 October, 2025
Objectives: The knowledge gap of whether a drug would transfer into milk has existed for most medicines since their drug…
Read morePoster: Drug/Disease Modelling - Safety
Application of Physiologically-Based Pharmacokinetics using Simcyp to predict the exposure to Valproic Acid in human milk and pediatrics
Thursday 16 October, 2025
Objectives: This work is part of the Innovative medicines initiative (IMI) research consortium and project ConcePTION, with the main goal…
Read moreA population pharmacokinetic model for sertraline in depressive patients during the perinatal period: prediction of infant drug exposure through placenta and human milk
Thursday 16 October, 2025
Introduction/Objectives: Depression affects around 10% of women during the perinatal period [1]. Sertraline, a selective serotonin reuptake inhibitor, is one…
Read morePopulation PK-PD modeling and simulation of zolpidem to evaluate dosage regimen for sex effect in healthy Korean volunteers
Thursday 16 October, 2025
Objectives: In 2013, the recommended initial dose of zolpidem changed to 5 mg for female in FDA[1]. The concern is…
Read moreA QSP model characterizing valproic acid -induced hyperammonemia and the impact of carnitine supplementation
Thursday 16 October, 2025
Introduction: Valproic acid (VPA) is a narrow therapeutic index drug widely prescribed for the treatment of epilepsy, psychiatric disorders and…
Read moreModel-based assessment of QT interval correction methods
Thursday 16 October, 2025
Objectives: ICH S7B and E14 guidances require that all compounds without intended effects on cardiac electrophysiology undergo ventricular repolarization safety assessment…
Read moreMixed effects modeling of concentration-QT relationships: first experiences with the new white paper
Thursday 16 October, 2025
Objectives: The ICH guidance documents on the analysis of drug effects on QT interval length [1, 2] were recently enhanced by…
Read moreApplication of the Quantitative System Toxicology model of drug-induced liver injury DILIsym to evaluate the hepatotoxic potential of drugs in early development
Thursday 16 October, 2025
Objectives: Hepatotoxicity is one of the most frequent cause of safety related withdrawals for the past fifty years. It is…
Read moremethodological characterization of qt/qtc in children with severe malaria anaemia receiving arthemether-lumefantrine preceded by quinine
Thursday 16 October, 2025
Objectives: Oral artemether-lumefantrine (AL) is often administered shortly after the completion of parenteral quinine in the treatment of hospitalized children…
Read morePharmacodynamic (PD) model of neutrophil margination to describe transient effect of sarilumab on absolute neutrophil count (ANC) in patients with rheumatoid arthritis (RA) after single-dose administration
Thursday 16 October, 2025
Objectives: To present a PD model that explains the time course of the decrease and recovery of ANC, describes potential margination…
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