Population Pharmacokinetic/Pharmacodynamic Analysis of Intravenous Zanamivir in Healthy Adults and Hospitalized Adult and Pediatric Subjects With Influenza
Autor: | Phillip J. Yates, Malek Okour, Jon Collins, Grace Roberts, Peiying Zuo, Helen A. Watson, Denise Shortino, Aline Barth, Mohammad Hossain, Amanda Peppercorn |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Male
030213 general clinical medicine Time Factors Datasets as Topic Pharmacology 030226 pharmacology & pharmacy 0302 clinical medicine Multicenter Studies as Topic Zanamivir General Pharmacology Toxicology and Pharmaceutics Child Host cell membrane Aged 80 and over education.field_of_study Inhalation biology General Neuroscience lcsh:Public aspects of medicine Age Factors virus diseases General Medicine Articles Middle Aged Viral Load Healthy Volunteers Hospitalization Influenza A virus Child Preschool Administration Intravenous Female medicine.drug Glomerular Filtration Rate Adult Adolescent Population Neuraminidase Antiviral Agents Models Biological General Biochemistry Genetics and Molecular Biology Article Drug Administration Schedule 03 medical and health sciences Young Adult Clinical Trials Phase II as Topic Pharmacokinetics Influenza Human medicine Humans Dosing education Aged Dose-Response Relationship Drug business.industry Research lcsh:RM1-950 Infant lcsh:RA1-1270 United States Renal Elimination lcsh:Therapeutics. Pharmacology Clinical Trials Phase III as Topic Pharmacodynamics biology.protein business |
Zdroj: | Clinical and Translational Science, Vol 13, Iss 1, Pp 157-168 (2020) Clinical and Translational Science |
ISSN: | 1752-8054 1752-8062 |
Popis: | Zanamivir is a potent and highly selective inhibitor of influenza neuraminidase in which the inhibition of this enzyme prevents the virus from infecting other cells and specifically prevents release of the new virion from the host cell membrane. It is available as an oral powder for inhalation and intravenous formulations. The current population pharmacokinetic model based on data from eight studies of subjects treated with the intravenous formulation (125 healthy adults and 533 hospitalized adult and pediatric subjects with suspected or confirmed influenza) suggested a decreased zanamivir clearance in pediatric and renal impairment adult subjects. It also indicates that b.i.d. dosing is necessary to keep the exposure in influenza infected subjects above the 90% inhibitory concentration values of recently circulating viruses over the dosing interval. In the exposure-response analysis (phases II and III studies), no apparent relationship was found between zanamivir exposure and clinically relevant pharmacodynamic end points. |
Databáze: | OpenAIRE |
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