Good pharmacogenomic practice

  • Email
  • Help
Current version

Draft guideline

Reference numberEMA/CHMP/268544/2016
Published02/05/2016
KeywordsPharmacogenomics, good practices, pharmacogenomic analyses, biomarkers, study design
DescriptionThis 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

Draft guideline



Concept paper

Published: 02/05/2016

Deadline for comments: 16/09/2016


Published: 04/08/2014


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more