A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01)(1)

AIMS: The pharmacokinetic (PK) similarity between PF-05280014, a proposed trastuzumab biosimilar, trastuzumab sourced from European Union (trastuzumab-EU) or from United States (trastuzumab-US) was evaluated. Safety and immunogenicity were also assessed. METHODS: In this phase 1, double-blind trial...

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Bibliographic Details
Published in:Br J Clin Pharmacol
Main Authors: Yin, Donghua, Barker, Kerry B, Li, Ruifeng, Meng, Xu, Reich, Steven D, Ricart, Alejandro D, Rudin, Dan, Taylor, Carrie T, Zacharchuk, Charles M, Hansson, Arne G
Format: Artigo
Language:Inglês
Published: BlackWell Publishing Ltd 2014
Subjects:
Clinical Trials
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC4256618/
https://ncbi.nlm.nih.gov/pubmed/25041377
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.12464
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