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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, Holger; Hill, Erin; Raabe, Hans; Tice, Raymond; Fitzpatrick, Suzanne; Devlin, Robert; Pinkerton, Kent; Oberdörster, Günter; Wright, Chris; Wieczorek, Roman; Aufderheide, Michaela; Steiner, Sandro; Krebs, Tobias; Asgharian, Bahman; Corley, Richard; Oldham, Michael; Adamson, Jason; Li, Xiang; Rahman, Irfan; Grego, Sonia; Chu, Pei-Hsuan; McCullough, Shaun; Curren, Rodger.
Afiliación
  • Behrsing H; Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
  • Hill E; Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
  • Raabe H; Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
  • Tice R; RTIce Consulting, Hillsborough, NC, USA.
  • Fitzpatrick S; US Food and Drug Administration, Silver Spring, MD, USA.
  • Devlin R; US Environmental Protection Agency, Research Triangle Park, NC, USA.
  • Pinkerton K; Center for Health and the Environment, University of California, Davis, CA, USA.
  • Oberdörster G; University of Rochester, Rochester, NY, USA.
  • Wright C; British American Tobacco (Investments) Ltd, Southampton, UK.
  • Wieczorek R; Imperial Tobacco Limited, Hamburg, Germany.
  • Aufderheide M; Cultex® Laboratories GmbH, Hannover, Germany.
  • Steiner S; Philip Morris Product SA, Neuchâtel, Switzerland.
  • Krebs T; Vitrocell® Systems GmbH, Waldkirch, Germany.
  • Asgharian B; Applied Research Associates, Albuquerque, NM, USA.
  • Corley R; Pacific Northwest National Laboratory, Richland, WA, USA.
  • Oldham M; Altria Client Services, LLC, Richmond, VA, USA.
  • Adamson J; British American Tobacco (Investments) Ltd, Southampton.
  • Li X; Zhengzhou Tobacco Research Institute of CNTC, Zhengzhou City, China.
  • Rahman I; University of Rochester Medical Center, Rochester, NY, USA.
  • Grego S; RTI International, Research Triangle Park, NC, USA.
  • Chu PH; National Center for Advancing Translational Sciences/National Institutes of Health, Rockville, MA, USA.
  • McCullough S; US Environmental Protection Agency, Research Triangle Park, NC, USA.
  • Curren R; Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
Altern Lab Anim ; 45(3): 117-158, 2017 Jul.
Article en En | MEDLINE | ID: mdl-28816053
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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fumar / Pruebas de Toxicidad / Productos de Tabaco Tipo de estudio: Prognostic_studies Aspecto: Ethics Límite: Animals / Humans País/Región como asunto: America do norte Idioma: En Revista: Altern Lab Anim Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fumar / Pruebas de Toxicidad / Productos de Tabaco Tipo de estudio: Prognostic_studies Aspecto: Ethics Límite: Animals / Humans País/Región como asunto: America do norte Idioma: En Revista: Altern Lab Anim Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido