The 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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Predictive biomarker-based assay development in the context of drug development and lifecycle
Published by EMA
EMAPredictive Biomarkers