Process map proposal for the validation of genomic biomarkers.
نویسندگان
چکیده
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.
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ورودعنوان ژورنال:
- Pharmacogenomics
دوره 7 5 شماره
صفحات -
تاریخ انتشار 2006