Process map proposal for the validation of genomic biomarkers.

@article{Goodsaid2006ProcessMP,
  title={Process map proposal for the validation of genomic biomarkers.},
  author={Federico M. Goodsaid and Felix W. Frueh},
  journal={Pharmacogenomics},
  year={2006},
  volume={7 5},
  pages={
          773-82
        }
}
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… CONTINUE READING

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