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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Bibliografske podrobnosti
izdano v:Ann Rheum Dis
Main Authors: Kaur, Primal, Chow, Vincent, Zhang, Nan, Moxness, Michael, Kaliyaperumal, Arunan, Markus, Richard
Format: Artigo
Jezik:Inglês
Izdano: BMJ Publishing Group 2017
Teme:
Clinical and Epidemiological Research
Online dostop: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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