Biomarker and Companion Diagnostics-A Review of Medicinal Products Approved by the European Medicines Agency.

Orellana García, Laura Patricia; Ehmann, Falk; Hines, Philip A; Ritzhaupt, Armin; Brand, Angela

Orellana García, Laura Patricia; Ehmann, Falk; Hines, Philip A; Ritzhaupt, Armin; Brand, Angela.

Afiliação

Orellana García LP; Department of International Health, Faculty of Health, Medicine and Life Sciences (FHLM), University of Maastricht, Maastricht, Netherlands.
Ehmann F; European Medicines Agency, Amsterdam, Netherlands.
Hines PA; European Medicines Agency, Amsterdam, Netherlands.
Ritzhaupt A; Department of International Health, Faculty of Health, Medicine and Life Sciences (FHLM), University of Maastricht, Maastricht, Netherlands.
Brand A; European Medicines Agency, Amsterdam, Netherlands.

Front Med (Lausanne) ; 8: 753187, 2021.

Article em En | MEDLINE | ID: mdl-34790681

Palavras-chave

CDx; EPAR; IVD; IVDR; SmPC (Summary of Product Characteristics); biomarker testing

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies / Guideline / Prognostic_studies Idioma: En Revista: Front Med (Lausanne) Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Holanda

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