Establishment of photosafety testing tools on the basis of physicochemical and biopharmaceutical data

2020 Fiscal Year Final Research Report

• Project/Area Number: 17K08453
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: University of Shizuoka
• Principal Investigator: Onoue Satomi 静岡県立大学, 薬学部, 教授 (00457912)
• Project Period (FY): 2017-04-01 – 2021-03-31
• Keywords: 光線過敏症 / 創薬 / 安全性

Outline of Final Research Achievements

To establish the reliable photosafety testing approach, model chemicals were subjected to photochemical, photobiochemical and pharmacokinetic characterization. Upon these data, photosafety testing tools were proposed with combination use of reactive oxygen species (ROS) assay and pharmacokinetic analysis. Preliminary validation testing was carried out for the proposed apporoach, and the ROS assay was successfully adopted as OECD test guideline 495 in 2019.

Free Research Field

薬剤科学

Academic Significance and Societal Importance of the Research Achievements

これまで現象論で捉えられる傾向にあった薬剤性光線過敏症の発症機序をはじめて統合的に理解することができ，さらに未だ確実な評価系に欠ける光安全性評価を可能となった．また，開発した試験法を多くの化合物に適用してデータを蓄積することで，各種光毒性反応を誘発しやすい化合物の構造上ならびに物性上の特性が明らかとなる．それによって各種光毒性反応に関する structural alert を新たに提示でき，医薬品・化粧品・食品をはじめとする新規化学物質の創製において極めて有用な情報を世界に向けて共有可能となるであろう．