E16 Qualification of Genomic Biomarkers
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context Structure and Format of Qualification Submissions
The ICH Harmonised Guideline was finalised under Step 4 in August 2010. The Guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15.
Date of Step 4: 20 August 2010
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
ICH E16 Qualification of Genomic Biomarkers Guidelines:
