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
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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