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A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects

AIMS: SB4 has been developed as a biosimilar of etanercept. The primary objective of the present study was to demonstrate the pharmacokinetic (PK) equivalence between SB4 and European Union ‐sourced etanercept (EU‐ETN), SB4 and United States‐sourced etanercept (US‐ETN), and EU‐ETN and US‐ETN. The sa...

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Detalles Bibliográficos
Autores principales: Lee, Yoon Jung, Shin, Donghoon, Kim, Youngdoe, Kang, Jungwon, Gauliard, Anke, Fuhr, Rainard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4917797/
https://www.ncbi.nlm.nih.gov/pubmed/26972584
http://dx.doi.org/10.1111/bcp.12929