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  • 标题:Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing
  • 本地全文:下载
  • 作者:Christian Schoergenhofer ; Michael Schwameis ; Christa Firbas
  • 期刊名称:Scientific Reports
  • 电子版ISSN:2045-2322
  • 出版年度:2018
  • 卷号:8
  • 期号:1
  • 页码:124
  • DOI:10.1038/s41598-017-17934-6
  • 语种:English
  • 出版社:Springer Nature
  • 摘要:(n = 8 proposed biosimilar, n = 4 reference product) of the proposed biosimilar or the reference product, respectively. It is important to understand that in healthy volunteers <1% of the authorized rituximab doses depletes almost all circulating B lymphocytes. Thus, for non-malignant diseases alternative, more cost-effective dosing regimens seem plausible, but require clinical testing. (EudraCT-No. 2010-023781-45; EudraCT-No. 2013-001077-24).
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