Výsledky vyhledávání - "Yasumasa, Arai"

Akademický článek

Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

Autor: Takuma Yonemura, Rie Yazawa, Miwa Haranaka, Kazuki Kawakami, Masayuki Takanuma, Takumi Kanzo, Dimitris Stefanidis, Yasumasa Arai

Publikováno v: BMC Pharmacology and Toxicology, Vol 23, Iss 1, Pp 1-11 (2022)

Abstract Background FKB327 has been developed as a biosimilar of the adalimumab reference product (RP). We compared the pharmacokinetics (PK), safety, and immunogenicity of FKB327 with those of the adalimumab RP after a single dose by subcutaneous (S

Externí odkaz: https://doaj.org/article/eeebeba3510b413bb1922f2cbe0455e9

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Akademický článek

Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies

Autor: Mark C Genovese, Rieke Alten, Herbert Kellner, Yasumasa Arai, Rafael Muniz

Publikováno v: RMD Open, Vol 6, Iss 1 (2020)

Background/Objective FKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients with active rheumatoid arthritis (R

Externí odkaz: https://doaj.org/article/fc91edecee2e4143a0b41227593bdd51

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Pharmacokinetics, safety, tolerability, and immunogenicity of FKB238, a new biosimilar of bevacizumab, in healthy participants

Autor: Malcolm Boyce, Denisa Wilkes, Hidekuni Kaito, Masayuki Takanuma, Yasumasa Arai

Publikováno v: International journal of clinical pharmacology and therapeutics. 60(6)

To compare the pharmacokinetics (PK), safety, tolerability, and immunogenicity of single intravenous doses of FKB238, a proposed biosimilar of bevacizumab, with European Union (EU)-approved and United States (US)-licensed bevacizumab in healthy parti

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5dd33a543753fe6a3b48a972ed7c0018
https://pubmed.ncbi.nlm.nih.gov/35361328

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Autor: Takuma Yonemura, Rie Yazawa, Miwa Haranaka, Kazuki Kawakami, Masayuki Takanuma, Takumi Kanzo, Dimitris Stefanidis, Yasumasa Arai

Publikováno v: BMC Pharmacology & Toxicology
BMC Pharmacology and Toxicology, Vol 23, Iss 1, Pp 1-11 (2022)

Background FKB327 has been developed as a biosimilar of the adalimumab reference product (RP). We compared the pharmacokinetics (PK), safety, and immunogenicity of FKB327 with those of the adalimumab RP after a single dose by subcutaneous (SC) inject

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a0a76a617f995d4cc6bb7de44667f2b5
https://pubmed.ncbi.nlm.nih.gov/34998419

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Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

Autor: Malcolm Boyce, Steve Warrington, Hideaki Nomura, Adeep Puri, Isobel Dalrymple, Andrew Niewiarowski, Yasumasa Arai, Mark Baird

Publikováno v: British Journal of Clinical Pharmacology. 83:1405-1415

Aims To compare the pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a biosimilar of adalimumab, with European Union (EU)-approved Humira and US-licensed Humira after single subcutaneous doses in healthy subjects. Methods In a ran

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c8d5134180f2a3dc1838f113a1d633ef
https://doi.org/10.1111/bcp.13245

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Systemic analysis of injection site pain caused by subcutaneous administration of FKB327 and reference product via different delivery methods v1

Autor: Takahiro Ito, Masayuki Takanuma, Yasumasa Arai

FKB327 is a biosimilar of the adalimumab reference product (RP). The formulation excipients of the FKB327 differ from those of the citrate-containing formulation of the RP, thus injection-site pain (ISP) at subcutaneous injection were assessed in sin

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::73e6352bcaa248a5481c8a1fb6dd33bf
https://doi.org/10.17504/protocols.io.3r2gm8e

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Autor: Herbert Kellner, Rafael Muniz, Yasumasa Arai, Mark C. Genovese, Rieke Alten

Publikováno v: RMD Open
RMD Open, Vol 6, Iss 1 (2020)

Background/ObjectiveFKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients with active rheumatoid arthritis (RA

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e8a7b36a4f64f3c74ce4fe918e9f576
https://pubmed.ncbi.nlm.nih.gov/32371430

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