A Systematic Database Approach to Identify Companion Diagnostic Testing in Clinical Trials under the New In Vitro Diagnostic Medical Devices Regulation

The European Union In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) introduces companion diagnostics (CDx) as a new legal term. CDx are applied in combination with a medicinal product to identify patient subgroups most likely to benefit from a treatment or who are at increased ris...

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Detalles Bibliográficos
Autores principales: Wollenhaupt, Clara, Sudhop, Thomas, Knoess, Werner
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296913/
https://www.ncbi.nlm.nih.gov/pubmed/37370933
http://dx.doi.org/10.3390/diagnostics13122037

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296913/
https://www.ncbi.nlm.nih.gov/pubmed/37370933
http://dx.doi.org/10.3390/diagnostics13122037

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