Good pharmacogenomic practice
| Current effective version | Adopted guideline Adopted guideline enters into effect 01/09/2018 |
| Reference number | EMA/CHMP/718998/2016 |
| Published | 19/03/2018 |
| Keywords | Pharmacogenomics, good practices, pharmacogenomic analyses, biomarkers, study design, pharmacokinetics, DNA sequencing |
| Description | 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. |
Document history
First version Current version |
| Published: 19/03/2018
Published: 02/05/2016
|
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