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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Detalhes bibliográficos
Publicado no:Ann Rheum Dis
Main Authors: Kaur, Primal, Chow, Vincent, Zhang, Nan, Moxness, Michael, Kaliyaperumal, Arunan, Markus, Richard
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group 2017
Assuntos:
Clinical and Epidemiological Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5445997/
https://ncbi.nlm.nih.gov/pubmed/27466231
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/annrheumdis-2015-208914
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