ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Scientific guideline
Table of contents
This 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.
Keywords: Genomic biomarkers
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ICH guideline E16: Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 5 (PDF/150.4 KB)
Adopted
First published: 11/02/2013
Last updated: 11/02/2013
Legal effective date: 01/12/2010
EMA/CHMP/ICH/380636/2009 -
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ICH: E 16: Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 3 (PDF/106.24 KB)
Draft: consultation closed
First published: 01/06/2009
Last updated: 01/06/2009
EMEA/CHMP/ICH/380636/2009