Publications by authors named "M A Mascelli"

Article Synopsis
  • Burosumab is approved to treat hypophosphatemia caused by persistent tumor-induced osteomalacia, utilizing a data-informed drug development method to assess its pharmacokinetics and dosing for both adults and children.
  • The study combined data from both tumor-induced osteomalacia and X-linked hypophosphatemia to refine understanding of drug behavior, using simulations to propose effective dosing recommendations that can achieve normal phosphate levels with minimal risk of hyperphosphatemia.
  • Findings suggest dosing for pediatric patients at 0.3 and 0.4 mg/kg every two weeks, and for adults at 0.3 and 0.5 mg/kg every four weeks, can lead
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The pharmacokinetics (PK) of naloxegol were characterized in pediatric subjects, aged 6 months or older to less than 18 years who either have or are at risk of developing opioid-induced constipation following single dose administration. Subjects grouped as aged 12 years or older to less than 18 years, 6 months or older to less than 12 years, and 6 months or older to less than 6 years, received a single oral dose of naloxegol at doses that were estimated to achieve plasma exposures comparable to adult 12.5- or 25-mg doses.

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Background: The innate immune system senses viral infection through pattern recognition receptors (PRRs), leading to type I interferon production. The role of type I interferon and PPRs in rhinovirus-induced asthma exacerbations in vivo are uncertain.

Objectives: We sought to compare bronchial mucosal type I interferon and PRR expression at baseline and after rhinovirus infection in atopic asthmatic patients and control subjects.

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Purpose: Icatibant is a bradykinin-2 receptor antagonist approved to treat acute hereditary angioedema attacks in adults. To-date, no thorough investigation of the clinical pharmacokinetic (PK) parameters of icatibant and its primary metabolites has been reported. Here we present the PK results of two phase I clinical studies of icatibant in healthy human volunteers.

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Intravenous enzyme replacement therapy with iduronate-2-sulfatase is an approved treatment for Hunter syndrome, however, conventional intravenous delivery cannot treat the neurologic manifestations of the disease due to its limited central nervous system penetration. Intrathecal administration of iduronate-2-sulfatase for delivery to the central nervous system is currently under investigation. The objective of this study was to evaluate the pharmacokinetics of idursulfase in the central nervous system of cynomolgus monkeys (Macaca fasicularis) after intravenous and intrathecal administration.

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