ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberEMEA/CHMP/ICH/380636/2009
Effective from01/12/2010
KeywordsGenomic biomarkers
DescriptionThis document describes the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products including translational medicine approaches, pharmacokinetics, pharmacodynamics, efficacy and safety aspects.

Document history

First version

Current version

Adopted guideline

Draft guideline

In operation: 01/12/2010–present

Published: 01/06/2009

Related content

How helpful is this page?

Average rating:

 Based on 35 ratings

Add your rating:

See all ratings
7 ratings
7 ratings
7 ratings
7 ratings
7 ratings

Tell us more