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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
Publicado en:Br J Clin Pharmacol
Main Authors: Lee, Yoon Jung, Shin, Donghoon, Kim, Youngdoe, Kang, Jungwon, Gauliard, Anke, Fuhr, Rainard
Formato: Artigo
Idioma:Inglês
Publicado: John Wiley and Sons Inc. 2016
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Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC4917797/
https://ncbi.nlm.nih.gov/pubmed/26972584
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.12929
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