Journal
PHARMACOGENOMICS
Volume 7, Issue 5, Pages 773-782Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/14622416.7.5.773
Keywords
biomarker; clinical; genomic; preclinical; validation
Categories
Ask authors/readers for more resources
How can we encourage the application of novel genomic biomarkers in drug development? A major step in this direction would be a consensus on how to interpret results from measurements of these biomarkers in regulatory submissions. A transparent process for genomic biomarker validation would be of value both for the pharmaceutical industry as well as for regulatory agencies associated with it. A discussion on process map proposals for genomic biomarker validation can help with drafting of guidance documents for this process.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available