Article 分子イメージングバイオマーカーの 世界標準化に向けて: QIBAの取り組みと医薬品開発への応用

栗原, 千絵子  ,  飯塚 均  ,  井上, 登美夫

44 ( 4 )  , pp.785 - 91 , 2017-04
practicality of quantitative imaging biomarkers, established by the Radiological Society of NorthAmerica (RSNA) in 2007. They are engaged in development of procedures of assessment and validation ofimaging biomarkers of various imaging modalities such as PET (positron emission tomography); MRI(magnetic resonance imaging); CT (computed tomography), and US (ultra sound), etc., to be utilized inboth clinical practice and therapeutic drug development. Main participants are radiologists and medicalphysicists, collaborating with stake holders such as industries of diagnostic devices, software, therapeuticdrugs, as well as regulatory authorities, such as United States Food and Drug Administration (FDA) andgovernmental institutes such as National Institute of Standards and Technology (NIST). They have formedseveral working groups of each modality to develop “QIBA profiles” which describe “claims” and“requirements” needed for assessment, validation, and standardization for the utility of each imagingbiomarker, which would be incorporated into specifications of imaging tools, as medical products.  In 2016, Japan Radiological Society (JRS) set up a working group to take part in QIBA’s initiative andhas been facilitating collaboration with international participants in this activity with prospects for thefuture possibility of global standardization of imaging biomarkers to be utilized in clinical practice, as wellas drug development.

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