Current situation on biomarker validation in Japan

Biomarkers are expected to be used as surrogate end points of drug efficacy and safety, and thus to accelerate drug development and promote proper use of drugs in medical practice. In Japan, biomarkers are regulatorily defined as “measurable characteristics as an indicator of normal biological processes, pathogenic processes and/or responses to therapeutic interventions” in the Technical Guidance on Development of In vitro Companion Diagnostics and Corresponding Therapeutic Products [1], which was released in December 2013 by the Ministry of Health, Labour and Welfare (MHLW). This definition is very close to that provided in the Biomarkers, EndpointS, and other Tools Resource,...

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