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

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/ICH/380636/2009
Published01/12/2010
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


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