转化医学与生物标志物资格认定的价值。
Translational medicine and the value of biomarker qualification.
机构信息
Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD 20903, USA.
出版信息
Sci Transl Med. 2010 Sep 1;2(47):47ps44. doi: 10.1126/scitranslmed.3001040.
PMID:20811041
Abstract
The gap between development of exploratory biomarkers and their acceptance in drug development and regulatory review is a hurdle in the development of better therapies. The U.S. Food and Drug Administration has developed a regulatory process for biomarker qualification to accelerate the process by which new biomarkers are integrated in the development of therapies.
摘要
探索性生物标志物的发展与其在药物开发和监管审查中的接受程度之间存在差距，这是开发更好疗法的一个障碍。美国食品和药物管理局已经制定了生物标志物资格认定的监管程序，以加速新生物标志物在治疗方法开发中的整合过程。
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