In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
| Autor: | Hans Raabe, Kent E. Pinkerton, Suzanne Fitzpatrick, Rodger Curren, Bahman Asgharian, Sonia Grego, Jason Adamson, Holger Behrsing, Chris J. Wright, Irfan Rahman, Erin Hill, Michaela Aufderheide, Richard A. Corley, Michael J. Oldham, Sandro Steiner, Shaun D. McCullough, Günter Oberdörster, Roman Wieczorek, Xiang Li, Tobias Krebs, Robert B. Devlin, Pei-Hsuan Chu, Raymond R. Tice |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Smoking prevention e-cigarette exposure systems Electronic Nicotine Delivery Systems tobacco exposure systems 010501 environmental sciences Toxicology 01 natural sciences Tobacco smoke In vitro model Regulatory authority 2.2 Factors relating to the physical environment Medicine Aetiology Lung Cancer in vitro models reconstructed epithelium airway models dosimetry Smoking Tobacco control in vitro Tobacco Products General Medicine Medical Laboratory Technology pulmonary models Respiratory in vitro lung Tobacco product medicine.medical_specialty In Vitro Techniques computational fluid dynamics Article General Biochemistry Genetics and Molecular Biology tobacco regulatory science 03 medical and health sciences Species Specificity Toxicity Tests Tobacco Animals Humans COPD Medical physics Veterinary Sciences 0105 earth and related environmental sciences Aerosols Tobacco Smoke and Health United States Food and Drug Administration business.industry Prevention ex vivo lung models In vitro exposure United States Good Health and Well Being 030104 developmental biology non-animal alternatives business |
| Zdroj: | Alternatives to laboratory animals : ATLA, vol 45, iss 3 Altern Lab Anim Scopus-Elsevier |
| ISSN: | 2632-3559 0261-1929 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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