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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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| Pubblicato in: | Br J Clin Pharmacol |
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| Autori principali: | , , , , , , , , , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
BlackWell Publishing Ltd
2014
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| Soggetti: | |
| Accesso online: | 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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