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Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan

WHAT IS KNOWN AND OBJECTIVES: In vitro companion diagnostic devices (CDx) provide information on pharmacogenomic biomarkers (PGBMs) to enable the safe and effective use of targeted agents for personalized therapy. These devices require specific regulations that strike a balance between scientific ev...

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Detalles Bibliográficos
Autores principales:	Shimazawa, R, Ikeda, M
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BlackWell Publishing Ltd 2014
Materias:	Pharmacogenetics
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4237189/ https://www.ncbi.nlm.nih.gov/pubmed/24405254 http://dx.doi.org/10.1111/jcpt.12129

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