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In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
Behrsing, Holger1; Hill, Erin1; Raabe, Hans1; Tice, Raymond2; Fitzpatrick, Suzanne3; Devlin, Robert4; Pinkerton, Kent5; Oberdorster, Gunter6; Wright, Chris7; Wieczorek, Roman8; Aufderheide, Michaela9; Steiner, Sandro10; Krebs, Tobias11; Asgharian, Bahman12; Corley, Richard13; Oldham, Michael14; Adamson, Jason7; Li, Xiang15; Rahman, Irfan16; Grego, Sonia17; Chu, Pei-Hsuan18; McCullough, Shaun4; Curren, Rodger1
发表日期2017-07-01
ISSN0261-1929
卷号45期号:3页码:117-158
英文摘要

In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. Specific topics were covered to assess the status of current in vitro smoke and aerosol/vapour exposure systems, as well as the various approaches and challenges to quantifying the complex exposures in in vitro pulmonary models developed for evaluating adverse pulmonary events resulting from tobacco product exposures. The four core topics covered were: a) Tobacco Smoke and E-Cigarette Aerosols; b) Air-Liquid Interface-In Vitro Exposure Systems; c) Dosimetry Approaches for Particles and Vapours/In Vitro Dosimetry Determinations; and d) Exposure Microenvironment/Physiology of Cells. The 2.5-day workshop included presentations from 20 expert speakers, poster sessions, networking discussions, and breakout sessions which identified key findings and provided recommendations to advance these technologies. Here, we will report on the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapour exposures. With the recent FDA publication of the final deeming rule for the governance of tobacco products, there is an unprecedented necessity to evaluate a very large number of tobacco-based products and ingredients. The questionable relevance, high cost, and ethical considerations for the use of in vivo testing methods highlight the necessity of robust in vitro approaches to elucidate tobacco-based exposures and how they may lead to pulmonary diseases that contribute to lung exposure-induced mortality worldwide.


英文关键词computational fluid dynamics;COPD;dosimetry;e-cigarette exposure systems;ex vivo lung models;in vitro;in vitro lung;in vitro models;non-animal alternatives;pulmonary models;reconstructed epithelium airway models;tobacco exposure systems;tobacco regulatory science
语种英语
WOS记录号WOS:000411887800007
来源期刊ATLA-ALTERNATIVES TO LABORATORY ANIMALS
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61955
作者单位1.Inst In Vitro Sci Inc, Gaithersburg, MD 20878 USA;
2.RTIce Consulting, Hillsborough, NC USA;
3.US FDA, Silver Spring, MD USA;
4.US EPA, Res Triangle Pk, NC USA;
5.Univ Calif Davis, Ctr Hlth & Environm, Davis, CA 95616 USA;
6.Univ Rochester, Rochester, NY USA;
7.British Amer Tobacco Investments Ltd, Southampton, Hants, England;
8.Imperial Tobacco Ltd, Hamburg, Germany;
9.Cultex Labs GmbH, Hannover, Germany;
10.Philip Morris Prod SA, Neuchatel, Switzerland;
11.Vitrocell Syst GmbH, Waldkirch, Germany;
12.Appl Res Associates, Albuquerque, NM USA;
13.Pacific Northwest Natl Lab, Richland, WA USA;
14.Altria Client Serv LLC, Richmond, VA USA;
15.Zhengzhou Tobacco Res Inst CNTC, Zhengzhou, Henan, Peoples R China;
16.Univ Rochester, Med Ctr, Rochester, NY 14642 USA;
17.RTI Int, Res Triangle Pk, NC USA;
18.NIH, Natl Ctr Adv Translat Sci, Rockville, MD USA
推荐引用方式
GB/T 7714
Behrsing, Holger,Hill, Erin,Raabe, Hans,et al. In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use[J]. 美国环保署,2017,45(3):117-158.
APA Behrsing, Holger.,Hill, Erin.,Raabe, Hans.,Tice, Raymond.,Fitzpatrick, Suzanne.,...&Curren, Rodger.(2017).In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use.ATLA-ALTERNATIVES TO LABORATORY ANIMALS,45(3),117-158.
MLA Behrsing, Holger,et al."In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use".ATLA-ALTERNATIVES TO LABORATORY ANIMALS 45.3(2017):117-158.
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