Predictive biomarker-based assay development in the context of drug development and lifecycle

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Concept paper

Deadline for comments: 15 November 2017

Reference numberEMA/CHMP/800914/2016
Published28/07/2017
Effective from 
KeywordsCompanion diagnostic (CDx), in vitro diagnostics (IVD), co-development, biomarkers, assay development, platforms, genetic testing, -omics, drug development
DescriptionThe proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug  development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.


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