Search Results

15 results

  1. CORESTA Meeting, Smoke Science/Product Technology, 2021, Online, ST 50

    In vivo genotoxicity testing of aerosols generated from JUUL ENDS products

    LALONDE G.(1); ZHANG Jingjie(2); JALIGAMA S.(3); GUPTA A.(3); PSURNY E.(3); LEE K.M.(2); DOSHI U.(2); YAO J.(1)
    (1) JUUL Labs, Inc., San Francisco, CA, U.S.A.; (2) Altria Client Services, LLC, Richmond, VA, U.S.A. (a Service Provider to Juul Labs, Inc.); (3) Battelle Memorial Institute, West Jefferson, OH, U.S.A.
    We evaluated the in vivo genotoxicity potential of aerosols generated from two commercial nicotine electronic delivery systems (ENDS) products, P1 and P2, with a combined micronucleus (MN) and comet study design based on OECD TG 474 and...
  2. CORESTA Meeting, Smoke Science/Product Technology, 2021, Online, ST 57

    Nonclinical toxicity assessment of oral tobacco-derived nicotine products: I. Framework

    ZHANG M.; SMITH C.; MORGAN R.; DOSHI U.; KUMAR A.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    There is an increasing acknowledgement of a broad "continuum of risk" among tobacco products, with combustible cigarettes at the highest end and non-combustible products toward the lower end of health risk. The oral tobacco-derived nicotine (OTDN)...
  3. CORESTA Meeting, Smoke Science/Product Technology, 2021, Online, ST 59

    Nonclinical toxicity assessment of oral tobacco-derived nicotine products: III. Extraction and test material characterization

    SMITH C.; ZHANG M.; HURST T.; DOSHI U.; KUMAR A.; MORGAN R.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    The oral tobacco-derived nicotine (OTDN) product category is one of the fastest growing tobacco product segments in the United States, offering alternative nicotine products that do not contain tobacco. A rigorous nonclinical toxicological assessment...
  4. CORESTA Meeting, Smoke Science/Product Technology, 2021, Online, ST 60

    Nonclinical toxicity assessment of oral tobacco-derived nicotine products: IV. In vitro regulatory testing

    DOSHI U.; SMITH C.; KUMAR A.; MORGAN R.; ZHANG M.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    The oral tobacco-derived nicotine (OTDN) product category is one of fastest growing tobacco product segments in the United States offering alternative nicotine products that do not contain tobacco. A rigorous, nonclinical, toxicological assessment,...
  5. CORESTA Meeting, Smoke Science/Product Technology, 2021, Online, ST 61

    Nonclinical toxicity assessment of oral tobacco-derived nicotine products: V. In vitro mechanistic assays using human gingival fibroblasts

    KUMAR A.; DOSHI U.; SMITH C.; MORGAN R.; ZHANG M.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    The oral tobacco-derived nicotine (OTDN) product category is one of the fastest growing tobacco product segments in the United States, offering alternative nicotine products that do not contain tobacco. A rigorous nonclinical toxicity assessment is...
  6. CORESTA Congress, Online, 2020, Smoke Science/Product Technology Groups, STPOST 16

    Comparison of in vitro cytotoxicity and genotoxicity of condensates derived from electronic-cigarettes and reference combustible cigarette

    DOSHI U.; GARDNER W.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    In recent years, electronic nicotine delivery systems (ENDS) including electronic cigarettes (e-cigarettes) have emerged as potential reduced-risk alternatives to conventional cigarettes for adult smokers. The U.S. Food and Drug Administration (FDA),...
  7. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 38

    In vitro cytotoxicity and genotoxicity of representative e-liquid flavor mixtures

    DOSHI U.; ZHANG J.; KUMAR A.; LEE K.M.
    Altria Client Services LLC, Richmond, VA 23219, U.S.A.
    Flavor compounds “generally recognized as safe” for oral consumption are commonly used in inhalable e-vapor products for which insufficient safety data exists. The hazard characterization of each flavor and various flavor mixtures is resource and...
  8. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 067

    Characterization of smokeless tobacco products extracted with different solvents for in vitro testing

    ZHANG JINGJIE (1); DOSHI U.(1); THAIKOOTTATHIL J.(1); LEE K.M.(1); WOLZ R.L.(2)
    (1) Altria Client Services, Richmond, VA, USA; (2) Enthalpy Analytical, Richmond, VA, USA
    Unlike cigarettes, there are no standardized methods available for preparing extracts from smokeless tobacco (SLT) products for in vitro toxicological evaluation. Methods are available for Harmful and Potentially Harmful constituents (HPHCs)...
  9. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 29 (also presented at TSRC 2018)

    Toxicological assessment of e-liquid formulations using in vitro genotoxicity and cytotoxicity assays

    COFFA B.G.; DOSHI U.; ZHANG J.; McKINNEY W.J.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    In the electronic nicotine delivery systems (ENDS) Premarket Tobacco Application (PMTA; 2016) Draft Guidance, the U.S. Food and Drug Administration (FDA) recommends a full assessment of the toxicological profile associated with new tobacco products,...
  10. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 30

    Effects of exposure to e-cigarette aerosols compared with cigarette smoke on 3D human buccal and small airway cultures: a systems toxicology assessment

    ISKANDER A.(1); STEINER S.(1); MAJEED S.(1); KONDYLIS A.(1); XIANG Yang(1); ZANETTI F.(1); FRENTZEL S.(1); MARTIN F.(1); PEITSCH M.C.(1); DOSHI U.(2); McKINNEY W.J.(2); LEE K.M.(2); HOENG J.(1)
    (1) Philip Morris Products S.A. (part of Philip Morris International group of companies), PMI R&D, Neuchâtel, Switzerland; (2) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond VA, U.S.A.
    Considerable attention has been given toward the reduced risk potential of e-cigarettes (e-cigs). Most in vitro studies have focused on testing e-liquid formulations directly on submerged 2D cultures. Here, we examined the effects of exposure to the...