A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis
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- 作者：Stanley Cohen ; Paul Emery ; Maria Greenwald ; Donghua Yin ; Jean-Claude Becker ; Lisa Ann Melia ; Ruifeng Li ; Barry Gumbiner ; Dolca Thomas ; George Spencer-Green and Xu Meng
- 刊名：British Journal of Clinical Pharmacology
- 出版年：2016
- 出版时间：July 2016
- 年：2016
- 卷：82
- 期：1
- 页码：129-138
- 全文大小：1252K
- ISSN：1365-2125
文摘
Pharmacokinetic (PK) similarity was assessed among PF-05280586 (a proposed biosimilar) vs. rituximab sourced from the European Union (rituximab-EU) and the United States (rituximab-US). Pharmacodynamics (PD), overall safety and immunogenicity were also evaluated.