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PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(®)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

BACKGROUND: Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen(®)) in healthy volunteers (HVs). MET...

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Detalles Bibliográficos
Autores principales: Yao, Hsuan-Ming, Ottery, Faith D., Borema, Troy, Harris, Stuart, Levy, Jeffrey, May, Tom B., Moosavi, Shahrzad, Zhang, Jeffrey, Summers, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439167/
https://www.ncbi.nlm.nih.gov/pubmed/30900158
http://dx.doi.org/10.1007/s40259-019-00343-8