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FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine.

作者信息

Luh Frank, Yen Yun

机构信息

Sino-American Cancer Foundation, Temple City, CA USA.

2PhD Program of Cancer Biology and Drug Discovery, TMU Research Center of Cancer Translational Medicine, Taipei Medical University, Taipei, Taiwan.

出版信息

NPJ Genom Med. 2018 Oct 3;3:28. doi: 10.1038/s41525-018-0067-2. eCollection 2018.

DOI:10.1038/s41525-018-0067-2
PMID:30302274
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6170456/
Abstract
摘要

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本文引用的文献

1
The FDA and genomic tests--getting regulation right.美国食品药品监督管理局与基因检测——确保监管正确无误。
N Engl J Med. 2015 Jun 4;372(23):2258-64. doi: 10.1056/NEJMsr1501194. Epub 2015 May 27.
2
Charting a course for genomic medicine from base pairs to bedside.为基因组医学绘制从碱基对到床边的路线图。
Nature. 2011 Feb 10;470(7333):204-13. doi: 10.1038/nature09764.
3
Cytochrome p-450 polymorphisms and response to clopidogrel.细胞色素P-450基因多态性与氯吡格雷的反应
N Engl J Med. 2009 Jan 22;360(4):354-62. doi: 10.1056/NEJMoa0809171. Epub 2008 Dec 22.
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Genomic medicine: genetic variation and its impact on the future of health care.基因组医学：基因变异及其对医疗保健未来的影响。
Philos Trans R Soc Lond B Biol Sci. 2005 Aug 29;360(1460):1543-50. doi: 10.1098/rstb.2005.1683.