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A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects

PURPOSE: This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 980 and trastuzumab in healthy males. METHODS: In this single-blind study, 157 healthy males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion of ABP 980, FDA-licensed trastuzumab [trastuzumab...

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Detalles Bibliográficos
Autores principales: Hanes, Vladimir, Chow, Vincent, Zhang, Nan, Markus, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5403841/
https://www.ncbi.nlm.nih.gov/pubmed/28341959
http://dx.doi.org/10.1007/s00280-017-3286-9