E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions

Regulatory Resource: E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions

Description:

This guideline has been released for consultation under Step 2 of the ICH process on 10 June 2009.
The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15.

Download Document: E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions

0.09 Megabytes