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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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| Publicado no: | J Clin Pharm Ther |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
BlackWell Publishing Ltd
2014
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| Assuntos: | |
| Acesso em linha: | 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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