Objectives: Quantitative Systems Pharmacology (QSP) models require their validation via comparison of model simulations with in vivo baseline data measured in…
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Physiologically-based pharmacokinetic modeling of ruxolitinib and posaconazole to predict the clinically relevant CYP3A4 mediated drug-drug interaction
Introduction: Ruxolitinib is an orally administered small molecule multi-kinase inhibitor with potent and selective inhibition activity against janus kinase 1/2…
Read morePopulation Pharmacokinetic-Pharmacogenetic Analysis of Osimertinib in patients with Non-Small Cell Lung Cancer
Objectives: Osimertinib is an oral third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved for the treatment of metastatic…
Read morePopulation pharmacokinetic modeling of ceftaroline characterizing tissue distribution following different ceftaroline fosamil infusion regimens to volunteers undergoing muscle and subcutaneous tissue microdialysis
Objectives: Ceftaroline fosamil (CPT-F), the prodrug of the β‐lactam ceftaroline (CPT), is a fifth-generation cephalosporine approved for the treatment of acute…
Read moreIdentifiability of drug effects in turn-over models with increasing complexity
IntroductionQuantitative system pharmacology (QSP) models are applied with increasing frequency to describe and study complex biological systems including drug effects…
Read moreQuantifying requirements for additional sedatives in critically-ill children using a repeated time to event analysis
Introduction: Protocolised sedation in critically-ill children guides the selection of sedatives and their dose during mechanical ventilation. Treatment failure occurs…
Read moreQuantifying the sensitivity and specificity of CYP450 probe drugs in predicting in vivo enzyme activity under (patho)physiological conditions
Introduction: CYP1A2, CYP2B6, CYP2C9, CYP2D6, and CYP3A4 are involved with more than 85% of drugs that are metabolized. Disease-related change…
Read moreSimulx-GUI: a flexible, fast and user-friendly application for simulations
Introduction: Now, more than ever, to increase drug success rate and accelerate clinical development, it is important to incorporate new…
Read moreOptimizing the sample size of a bridging study using Simulx, an application of the MonolixSuite
Objectives: Clinical trial simulations can guide the design of phase 3 trials, e.g. by suggesting the minimum sample size required…
Read morePharmacokinetic Modeling of Fentanyl Citrate and Norfentanyl in Calves Using a Nonlinear Mixed-Effects Approach
Objectives: Fentanyl citrate is a potent opioid agonist commonly used as an analgesic in animal studies, providing several hours of…
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