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A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab

OBJECTIVE: To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501. METHODS: Randomised, single-blind, single-dose, three-arm, parallel...

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Detalles Bibliográficos
Autores principales: Kaur, Primal, Chow, Vincent, Zhang, Nan, Moxness, Michael, Kaliyaperumal, Arunan, Markus, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5445997/
https://www.ncbi.nlm.nih.gov/pubmed/27466231
http://dx.doi.org/10.1136/annrheumdis-2015-208914