PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta(®)): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

INTRODUCTION: PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta(®)). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta(®)) in healthy volunteers. METHODS: A ph...

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Detalles Bibliográficos
Autores principales: Moosavi, Shahrzad, Borema, Troy, Ewesuedo, Reginald, Harris, Stuart, Levy, Jeffrey, May, Thomas B., Summers, Martin, Thomas, Jeffrey S., Zhang, Jeffrey, Yao, Hsuan-Ming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2020
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467414/
https://www.ncbi.nlm.nih.gov/pubmed/32524499
http://dx.doi.org/10.1007/s12325-020-01387-x

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