Biomarker-Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union.

Verbaanderd, Ciska; Trullás Jimeno, Ana; Engelbergs, Jörg; Zander, Hilke; Reischl, Ilona; Moreno Oliver, Ana; Vamvakas, Spiros; Vleminckx, Camille; Bouygues, Christelle; Girard, Thomas; Day, Francesca; Frias, Zaide

Verbaanderd, Ciska; Trullás Jimeno, Ana; Engelbergs, Jörg; Zander, Hilke; Reischl, Ilona; Moreno Oliver, Ana; Vamvakas, Spiros; Vleminckx, Camille; Bouygues, Christelle; Girard, Thomas; Day, Francesca; Frias, Zaide.

Afiliación

Verbaanderd C; PhaRA Consulting, Antwerp, Belgium.
Trullás Jimeno A; European Medicines Agency, Amsterdam, The Netherlands.
Engelbergs J; Paul Ehrlich Institute, Langen, Germany.
Zander H; Paul Ehrlich Institute, Langen, Germany.
Reischl I; Austrian Agency for Health and Food Safety, Wien, Austria.
Moreno Oliver A; Spanish Agency for Medicines and Health Care Products, Madrid, Spain.
Vamvakas S; European Medicines Agency, Amsterdam, The Netherlands.
Vleminckx C; European Medicines Agency, Amsterdam, The Netherlands.
Bouygues C; European Medicines Agency, Amsterdam, The Netherlands.
Girard T; European Medicines Agency, Amsterdam, The Netherlands.
Day F; European Medicines Agency, Amsterdam, The Netherlands.
Frias Z; European Medicines Agency, Amsterdam, The Netherlands.

Clin Pharmacol Ther ; 114(2): 316-324, 2023 08.

Article en En | MEDLINE | ID: mdl-37132507

Asunto(s)

Medicina de Precisión; Humanos; Unión Europea; Medicina de Precisión/métodos; Biomarcadores

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicina de Precisión Tipo de estudio: Diagnostic_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Estados Unidos

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