Good pharmacogenomic practice
Table of contents
This document describes requirements related to the choice of appropriate genomic methodologies during the development and the life-cycle of a drug. It discusses the principles for a robust clinical genomic dataset. It also highlights the key scientific and technological aspects for the determination and interpretation of the genomic biomarker data and their translation into clinical practice.
Keywords: Pharmacogenomics, good practices, pharmacogenomic analyses, biomarkers, study design, pharmacokinetics, DNA sequencing
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Guideline on good pharmacogenomic practice - First version (PDF/193.32 KB)
Adopted
First published: 19/03/2018
Last updated: 13/07/2018
Legal effective date: 01/09/2018
EMA/CHMP/718998/2016 -
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Draft guideline on good pharmacogenomic practice - First version (PDF/212.35 KB)
Draft: consultation closed
First published: 02/05/2016
Last updated: 02/05/2016
Consultation dates: 02/05/2016 to 16/09/2016
EMA/CHMP/268544/2016 -
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Concept paper on good genomics biomarker practices - First version (PDF/91.95 KB)
Draft: consultation closed
First published: 04/08/2014
Last updated: 04/08/2014
Consultation dates: 04/08/2014 to 04/11/2014
EMA/CHMP/PGWP/415990/2014