Goodsaid Federico, Frueh Felix
US Food and Drug Administration, Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 21, Room 3663, Silver Spring, MD 20903-0002, USA.
Pharmacogenomics. 2006 Jul;7(5):773-82. doi: 10.2217/14622416.7.5.773.
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.
我们如何鼓励新型基因组生物标志物在药物开发中的应用？朝着这个方向迈出的重要一步将是就如何在监管申报中解释这些生物标志物测量结果达成共识。基因组生物标志物验证的透明流程对制药行业及其相关监管机构都将具有价值。关于基因组生物标志物验证流程地图提案的讨论有助于起草该流程的指导文件。
