Pediatric Development of Bosentan
The particular sponsor of the first Iranian exhibition of work
February 27, 2018Analgesic plasma concentrations of oxycodone
March 10, 2018
Pediatric Development of Bosentan Facilitated by Modeling and Simulation
ABSTRACT
Background Bosentan is approved for use in adult patients with pulmonary arterial hypertension. The primary aim of the pharmacokinetic modeling was the provision of a systematic guidance for study design and enhanced understanding of pharmacokinetics across the entire pediatric age range.
Methods A physiologically based pharmacokinetic model was developed for the pediatric population; starting from
an adult model, the effects of body weight, age, and maturation of relevant metabolizing enzymes were incorporated
to extrapolate the pharmacokinetics to children. A pediatric population pharmacokinetic model was developed
to identify relevant covariates.
Results Based on model predictions, a dose of 0.5 mg/kg led to an exposure distinguishable from a dose of 2 mg/kg,
and an additional blood sampling time point at 2 h (the predicted time of maximum concentration) allowed more
precise estimation of bosentan exposure in children.
Background Bosentan is approved for use in adult patients with pulmonary arterial hypertension. The primary aim of the pharmacokinetic modeling was the provision of a systematic guidance for study design and enhanced understanding of pharmacokinetics across the entire pediatric age range.
Methods A physiologically based pharmacokinetic model was developed for the pediatric population; starting from
an adult model, the effects of body weight, age, and maturation of relevant metabolizing enzymes were incorporated
to extrapolate the pharmacokinetics to children. A pediatric population pharmacokinetic model was developed
to identify relevant covariates.
Results Based on model predictions, a dose of 0.5 mg/kg led to an exposure distinguishable from a dose of 2 mg/kg,
and an additional blood sampling time point at 2 h (the predicted time of maximum concentration) allowed more
precise estimation of bosentan exposure in children.
