Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for an Analytically Highly Similar Pegfilgrastim

A phase 1 pharmacokinetic (PK) and pharmacodynamic (PD) study was conducted to demonstrate similarity of a proposed pegfilgrastim biosimilar to its reference product. In a single‐dose, randomized, assessor‐blinded, 2‐way crossover, active‐controlled PK/PD study, 66 healthy adults received the propos...

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Detalles Bibliográficos
Autores principales: Desai, Kalpna, Catalano, Tina, Rai, Gurinder, Misra, Priya, Shah, Nirmesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094503/
https://www.ncbi.nlm.nih.gov/pubmed/27138868
http://dx.doi.org/10.1002/cpdd.269

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094503/
https://www.ncbi.nlm.nih.gov/pubmed/27138868
http://dx.doi.org/10.1002/cpdd.269

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