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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...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:J Clin Pharm Ther
Egile Nagusiak: Shimazawa, R, Ikeda, M
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: BlackWell Publishing Ltd 2014
Gaiak:
Sarrera elektronikoa:https://ncbi.nlm.nih.gov/pmc/articles/PMC4237189/
https://ncbi.nlm.nih.gov/pubmed/24405254
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/jcpt.12129
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