辐射生物剂量学和医疗对策研究生物标志物的开发：现状、效用和监管途径。
Development of Biomarkers for Radiation Biodosimetry and Medical Countermeasures Research: Current Status, Utility, and Regulatory Pathways.
机构信息
Radiation and Nuclear Countermeasures Program (RNCP), Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland.
出版信息
Radiat Res. 2022 May 1;197(5):514-532. doi: 10.1667/RADE-21-00157.1.
Abstract
Biomarkers are important indicators of biological processes in health or disease. For this reason, they play a critical role in advanced development of radiation biodosimetry tools and medical countermeasures (MCMs). They can aid in the assessment of radiation exposure level, extent of radiation-induced injury, and/or efficacy of a MCM. This meeting report summarizes the presentations and discussions from the 2020 workshop titled, "Biomarkers in Radiation Biodosimetry and Medical Countermeasures" sponsored by the Radiation and Nuclear Countermeasures Program (RNCP) within the National Institute of Allergy and Infectious Diseases (NIAID). The main goals of this meeting were to: 1. Provide an overview on biomarkers and to focus on the state of science with regards to biomarkers specific to radiation biodosimetry and MCMs; 2. Understand developmental challenges unique to the role of biomarkers in the fields of radiation biodosimetry and MCM development; and 3. Identify existing gaps and needs for translational application.
摘要
生物标志物是健康或疾病中生物过程的重要指标。因此，它们在先进的辐射生物剂量学工具和医疗对策（MCM）的开发中起着关键作用。它们可以帮助评估辐射暴露水平、辐射引起的损伤程度和/或 MCM 的疗效。本会议报告总结了由过敏和传染病研究所（NIAID）内的辐射和核对策计划（RNCP）主办的 2020 年题为“辐射生物剂量学和医疗对策中的生物标志物”的研讨会的介绍和讨论。本次会议的主要目标是：1. 提供生物标志物的概述，并重点介绍与辐射生物剂量学和 MCM 特异性生物标志物相关的科学现状；2. 了解生物标志物在辐射生物剂量学和 MCM 开发领域中的独特发展挑战；3. 确定转化应用的现有差距和需求。
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2
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