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- W2125012503 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." @default.
- W2125012503 created "2016-06-24" @default.
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- W2125012503 date "2006-07-01" @default.
- W2125012503 modified "2023-10-16" @default.
- W2125012503 title "Process map proposal for the validation of genomic biomarkers" @default.
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- W2125012503 doi "https://doi.org/10.2217/14622416.7.5.773" @default.
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