Process map proposal for the validation of genomic biomarkers
- 1 July 2006
- journal article
- review article
- Published by Future Medicine Ltd in Pharmacogenomics
- Vol. 7 (5), 773-782
- https://doi.org/10.2217/14622416.7.5.773
Abstract
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.Keywords
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