Thursday 16 October, 2025
Objectives: The most common treatment-emergent adverse events for an experimental drug (LY) were gastrointestinal, with nausea (N) and vomiting (V) among…
Read morePoster: Drug/Disease modeling - Safety
Population pharmacokinetics of the selective S1P1 receptor modulator ponesimod
Thursday 16 October, 2025
Objectives: Development of a population pharmacokinetic (PK) model for the characterization of the reversible, orally active, selective S1P1 receptor modulator ponesimod,…
Read moreA PK/PD meta-analysis to assess inter-study variability and translational value of preclinical exposure-QTc predictions
Thursday 16 October, 2025
Objectives: Drug-induced QTc-interval prolongation (?QTc) is assessed in preclinical cardiovascular safety studies as a surrogate for pro-arrhythmic risk in human. These…
Read morePower of PKPD analysis to detect QTc effect in preclinical setting
Thursday 16 October, 2025
Objectives: This simulation study aimed at investigating the power of PKPD modeling to detect different magnitudes of QT-prolongation in preclinical cardiovascular…
Read moreModeling Recurrent Safety Events in Drug Combinations using a Time-Varying Poisson Process
Thursday 16 October, 2025
Objectives: In phase I oncology studies a recommended phase II dose (RPIID) is declared at an early stage. With prolonged exposure…
Read moreRobust QT prolongation assessment using model-averaging
Thursday 16 October, 2025
Objectives: TQT studies are pivotal safety studies which assess whether a drug prolongs the QT interval by 10 ms or more….
Read moreAn integrated pharmacokinetic-pharmacodynamic modeling analysis of T-DM1–induced thrombocytopenia and hepatotoxicity in patients with HER2-positive metastatic breast cancer
Thursday 16 October, 2025
Objectives: T-DM1 is an antibody-drug conjugate for HER2-positive metastatic breast cancer and is associated with Grade 3/4 adverse events (AE)…
Read morePopulation PK/PD modelling of QT-interval prolongation in awake dogs and humans
Thursday 16 October, 2025
Objectives: Drug-induced Torsades de Pointes (TdP) and consequent sudden cardiac death are positively correlated with QT-interval prolongation. Conversely, not all “QT-prolonging…
Read moreExploring risk factors for everolimus discontinuation and serious side effects in renal transplant recipients on everolimus and prednisolone dual therapy.
Thursday 16 October, 2025
Objectives: Everolimus is an emergent non-nephrotoxic alternative for calcineurin inhibitors with substantial potential non-renal benefits in renal transplantation. Despite its proven…
Read moreA Method to Perform PK-QT Analyses When Several Active Compounds or Metabolites Are Present
Thursday 16 October, 2025
Objectives: To develop a statistically sound approach for PK-QT analysis when jointly modeling the impact of two active compounds by…
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