Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop.
Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop.
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DOI：
10.1158/1055-9965.epi-16-0675
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发表时间：
2017-03
期刊：
影响因子：
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通讯作者：
Hatsukami DK
中科院分区：
文献类型：
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作者：
Chang CM;Edwards SH;Arab A;Del Valle-Pinero AY;Yang L;Hatsukami DK
自2009年以来，美国（美国）美国食品和药物管理局（FDA）烟草制品中心（CTP）有权监管烟草制品的制造，分销和营销，以减少烟草使用引起的死亡和疾病。暴露的生物标志物与人类实际暴露于烟草使用产生的化学品有关，可以在FDA的许多监管活动中发挥重要作用，包括评估新的和修改的风险烟草产品以及确定和评估潜在的产品标准。2015年8月3日至4日，FDA/CTP主办了一次公共研讨会，重点关注来自政府、行业、学术界和其他组织的参与者的暴露生物标志物。研讨会分为四个部分，重点是：1）评估和选择生物标志物的方法; 2）暴露的生物标志物及其与疾病风险的关系; 3）目前使用的暴露生物标志物和正在开发的生物标志物;以及4）暴露的生物标志物和无烟烟草和电子尼古丁输送系统（ENDS）的评估。本文综合了研讨会的主要研究结果，并强调了可以进一步加强暴露生物标志物科学的研究领域，并有助于确定其在烟草产品监管中的应用。
Since 2009, the United States (U.S.) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards. On August 3–4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: 1) approaches to evaluating and selecting biomarkers; 2) biomarkers of exposure and relationship to disease risk; 3) currently-used biomarkers of exposure and biomarkers in development; and 4) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems (ENDS). This paper synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation.