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Tajima N, Martinez A, Kobayashi F, et al. A phase 1 study comparing the proposed biosimilar BS-503a with bevacizumab in healthy male volunteers. Pharmacol Res Perspect. 2017;5(2):e00286doi: 10.1002/prp2.286.
Tajima, N., Martinez, A., Kobayashi, F., He, L., & Dewland, P. (2017). A phase 1 study comparing the proposed biosimilar BS-503a with bevacizumab in healthy male volunteers. Pharmacology research & perspectives, 5(2), e00286. https://doi.org/10.1002/prp2.286
Tajima, Naoyuki, et al. "A phase 1 study comparing the proposed biosimilar BS-503a with bevacizumab in healthy male volunteers." Pharmacology research & perspectives vol. 5,2 (2017): e00286. doi: https://doi.org/10.1002/prp2.286
Tajima N, Martinez A, Kobayashi F, He L, Dewland P. A phase 1 study comparing the proposed biosimilar BS-503a with bevacizumab in healthy male volunteers. Pharmacol Res Perspect. 2017 Feb 20;5(2):e00286. doi: 10.1002/prp2.286. eCollection 2017 Apr. PMID: 28357118; PMCID: PMC5368956.
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Pharmacol Res Perspect. 2017 Feb 20;5(2):e00286. doi: 10.1002/prp2.286. eCollection 2017 Apr.

A phase 1 study comparing the proposed biosimilar BS-503a with bevacizumab in healthy male volunteers.

Pharmacology research & perspectives

Naoyuki Tajima, Alberto Martinez, Fumiaki Kobayashi, Ling He, Peter Dewland

Affiliations

  1. Daiichi Sankyo Co., Ltd. 1-2-58 Hiromachi Shinagawa-ku Tokyo 140-8710 Japan.
  2. Daiichi Sankyo Development Ltd. Chiltern Place, Chalfont Park Gerrards Cross SL9 0BG United Kingdom.
  3. Daiichi Sankyo Pharma Development 399 Thornall Street Edison New Jersey 08837.

PMID: 28357118 PMCID: PMC5368956 DOI: 10.1002/prp2.286

Abstract

This is a randomized, double-blind, single-dose, parallel group phase 1 study to assess pharmacokinetic similarity, safety, and tolerability of BS-503a, a proposed bevacizumab biosimilar. A total of 114 male healthy subjects were randomized (1:1) to receive a single 3 mg/kg intravenous dose of either BS-503a or bevacizumab (Avastin

Keywords: BS‐503a; bevacizumab; biosimilar; healthy male volunteers; pharmacokinetics; safety; similarity

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