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Population Pharmacokinetics of Doripenem in Pediatric Patients and Monte-Carlo Pharmacokinetic/Pharmacodynamic Simulations for Dosing Regimen Assessment.

08:00 EDT 8th April 2019 | BioPortfolio

Summary of "Population Pharmacokinetics of Doripenem in Pediatric Patients and Monte-Carlo Pharmacokinetic/Pharmacodynamic Simulations for Dosing Regimen Assessment."

The aims of this study were to evaluate the pharmacokinetics of doripenem (Finibax®, Doribax®, S-4661), a parenteral carbapenem antibiotic, in pediatric patients based on concentrations of doripenem in plasma after administration of 20 mg/kg two or three times daily and to evaluate the dosing regimens by using Monte-Carlo pharmacokinetic/pharmacodynamic simulations. Population pharmacokinetic analysis was performed by using 190 plasma concentrations of doripenem from 99 patients (2months - 13years old). The two-compartment model well described the doripenem plasma concentrations in pediatric patients. Body weight was found to be the most significant influential factor. Gender was also found to be a significant covariate although the effect was relatively small. Monte-Carlo simulations indicated that 20 mg/kg over I hour infusion would give 90% probability of target attainment for 40% of time above minimum inhibitory concentration (MIC) against Haemophilus influenzae and Streptococcus pneumoniae, major causative pathogens in pediatric infections, and that 40 mg/kg, the highest approved dose for Japanese pediatric patients, administered over 3 hours infusion achieved 98.6% against 8 μg/mL. The developed population pharmacokinetic model of doripenem and Monte-Carlo simulations for pediatric patients should provide useful information for understanding the pharmacokinetic and PK/PD characteristics of doripenem and for optimal treatment of pediatric patients.

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This article was published in the following journal.

Name: Journal of pharmaceutical sciences
ISSN: 1520-6017
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