A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.
Bioanalysis
; : 1-8, 2024 Aug 05.
Article
em En
| MEDLINE
| ID: mdl-39101487
ABSTRACT
The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.
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1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Alemanha