文章基本信息

标题：Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing
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作者：Christian Schoergenhofer ; Michael Schwameis ; Christa Firbas 等
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).