Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Arrieta AC, Neely M, Day JC, Rheingold SR, Sue PK, Muller WJ, Danziger-Isakov LA, Chu J, Yildirim I, McComsey GA, Frangoul HA, Chen TK, Statler VA, Steinbach WJ, Yin DE, Hamed K, Jones ME, Lademacher C, Desai A, Micklus K, Phillips DL, Kovanda LL, Walsh TJ. Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients. Antimicrobial Agents And Chemotherapy 2021, 65: 10.1128/aac.00290-21. PMID: 34031051, PMCID: PMC8284446, DOI: 10.1128/aac.00290-21.Peer-Reviewed Original ResearchConceptsPhase 1 studyPediatric patientsIsavuconazonium sulfatePlasma drug exposureDrug exposureOral administrationImmunocompromised Pediatric PatientsNew triazole agentProdrug isavuconazonium sulfateTolerability of isavuconazoleBody mass indexPopulation PK modelInvasive fungal infectionsProbability of targetTarget rangeConcentration-time curveFirst-order inputMass indexPopulation pharmacokineticsStepwise covariate modelingTriazole agentsClinical dosePK parametersLinear eliminationPatients