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

Authors :: Arne G. Hansson
Ruifeng Li
Charles Zacharchuk
Dan Rudin
Alejandro D. Ricart
Xu Meng
Donghua Yin
Steven D. Reich
Carrie T. Taylor
Kerry B. Barker
Source :: British Journal of Clinical Pharmacology. 78:1281-1290
Publication Year :: 2014
Publisher :: Wiley, 2014.
Abstract: 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.

Subjects :: Pharmacology
business.industry
Immunogenicity
Biosimilar
Pharmacokinetics
Trastuzumab
Healthy volunteers
Area under curve
media_common.cataloged_instance
Medicine
Pharmacology (medical)
European union
skin and connective tissue diseases
business
neoplasms
media_common
medicine.drug

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