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FDA的“使用组织病理学及其相关方法支持生物标志物鉴定应考虑的问题”指导原则介绍

Introduction of FDA's Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry
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摘要 FDA于2016年5月公布了"使用组织病理学及其相关方法支持生物标志物鉴定应考虑的问题"指导原则。该指导原则概述了组织病理学非临床生物标志物的特点,详述了这种非临床生物标志物鉴定中使用组织病理学方法的科学标准。本文介绍该指导原则的主要内容,期望对我国这方面的研究和监管有所帮助。 FDA issued Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry in May 2016. The guideline outlined the characteristics of nonclinical biomarker of histopathology, and explained the scientific standards for the use of histopathological methods in the nonclinical biomarker qualification. This paper introduces the main contents of the guideline, and it is expected to be helpful to the research and supervision in our country.
作者 萧惠来
机构地区 国家食品药品监督管理总局药品审评中心
出处 《药物评价研究》 CAS 2017年第1期5-10,共6页 Drug Evaluation Research
关键词 美国食品药品管理局 非临床生物标志物 组织病理学 鉴定 方法学 指导原则 FDA nonclinical biomarker histopathology qualification methodology guideline
分类号 R954 [医药卫生—药学]
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药物评价研究
2017年 第1期

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