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Inventi Impact: Biosimilars & Biopharmaceuticals

Articles

  • Inventi:pbs/30666/19
    A Phase I, Randomized, Single-Dose Study Evaluating the Biosimilarity of TAB008 to Bevacizumab in\nHealthy Volunteers
    Research 2020 : January - March
    Jin Wang, Lu Qi, Long Liu, Zejuan Wang, Gang Chen, Yu Wang, Xiaona Liu, Ying Liu, Huijuan Liu, Yuanxu Tong, Chen Liu, Chunpu Lei, Xinghe Wang

    Objective: This study compared the pharmacokinetics (PK), safety, and immunogenicity\nof the biosimilar TAB008 monoclonal antibody to bevacizumab (AvastinR) in normal\nhealthy Chinese male volunteers.\nMethods: In this randomized, double-blind, parallel controlled study, a total of 100 healthy\nChinese male subjects were randomized (1:1) to receive a single 1 mg/kg intravenous dose\nof TAB008 or AvastinR over a 90-min infusion. The subjects were followed for 99 days after\ndrug administration. Primary endpoints were bioequivalence of major pharmacokinetic\nparameters�����.

    How to Cite this Article
    Attribution/ CC Compliant Citation: Wang, Jin, et al. \"A Phase I, randomized, single-dose study evaluating the biosimilarity of TAB008 to\nbevacizumab in healthy volunteers.\" Frontiers in pharmacology 10 (2019); https://doi: 10.3389/fphar.2019.00905; http://\ncreativecommons.org/licenses/by/4.0/;Some formatting elements, header, footer, logos, dates and pagination were modified while adapting\nthis article.
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