Qualification is a conclusion that, within the stated context of use, the results of assessment with a biomarker can be relied upon to adequately reflect a biological process, response or event, and support use of the biomarker during drug or biotechnology product development, ranging from discovery through post-approval.〔【出典】ICHガイドライン 〕
It is expected that a biomarker proposed for qualification would facilitate drug or biotechnology product development program(s) or drug or biotechnology product use and could offer an improvement over currently available biomarkers or safety or efficacy endpoint assessments.〔【出典】ICHガイドライン 〕
適格性確認プロセス
qualification process
適格性規則
well-formedness rule
適格性認定
accreditation(主に教育機関の)
適格患者
eligible patient《医》
適格手形
eligible paper
適格投資
eligible investment
適格投資会社
regulated investment company《税務》〈米〉〔【略】RIC〕
適格投資家
accredited investor
適格担保
eligible collateral
eligible security
適格期間
eligibility period
適格株式オプション制度
qualified stock option plan
適格機関投資家
qualified institutional buyer《米証券法》〔【略】QIB〕
qualified institutional investor《金融》
適格機関投資家の範囲を拡大する
expand the scope of qualified institutional investors
A Financial Instruments Business Operator, etc. who engages in Specially Permitted Businesses for Qualified Institutional Investor, etc. (excluding those who have obtained registration under Article 29 or Article 33-2 for engaging in acts listed in the items of Article 63(1) in the course of trade) shall notify the Prime Minister to that effect and of the Category of Business prescribed in Article 63(2)(v) in advance, pursuant to the provisions of a Cabinet Office Ordinance.〔【出典】日本法令外国語訳データベースシステム 〕