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  1. CORESTA Congress, Online, 2020, Smoke Science/Product Technology Groups, ST 25

    Human abuse liability assessment of tobacco and nicotine products: considerations to meet current regulatory recommendations

    BAXTER S.(1); VANSICKEL A.(2); SHERWOOD N.(3); CAMPBELL L.(1); KONG M.(4)
    (1) RAI Services Company, Winston Salem, NC, U.S.A.; (2) Altria Client Services, Richmond, VA, U.S.A.; (3) Neil Sherwood Consulting, Nyon, Switzerland; (4) Altasciences Clinical Research, Laval, QC, Canada
    The U.S. Food and Drug Administration (FDA) recommends that tobacco product manufacturers provide information regarding the abuse liability of tobacco and nicotine-containing products to support pre-market tobacco, modified risk tobacco product and...
  2. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, ST 12

    Review of current methodologies in evaluating abuse liability of nicotine and tobacco products in the U.S. regulatory environment

    EVANS S.(1); KONG M.C.(2); CAMPBELL L.(2); SHERWOOD N.(3); PRASAD K.(4)
    (1) Turning Point Brands, Louisville, KY, U.S.A.; (2) Altasciences Clinical Research, Laval, Canada; (3) Neil Sherwood Consulting, Nyon, Switzerland; (4) British American Tobacco, R&D, Millbrook, Southampton, U.K.
    Traditional definitions of abuse and misuse do not apply to a consumer product such as tobacco that consumers essentially use ‘as intended’. In contrast to pharmaceutical products, a guidance for abuse liability testing of nicotine and tobacco...
  3. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 044

    Abuse liability of very low nicotine content cigarettes with characterization of nicotine exposure profiles in adult smokers

    LEVY-COOPERMAN N.(1); SHRAM M.J.(1); KELSH D.(2); VINCE B.(2); CARMINES E.(3)
    (1) Altreos Research Partners, Toronto, ON, Canada; (2) Altasciences/Vince and Associates, Overland Park, KS, USA; (3) Carmines Consulting, Scottsdale, AZ, USA
    Objectives: In 2017, FDA announced the intention to explore limiting nicotine in cigarettes to minimal/non-addictive levels. Research indicates that reduced nicotine content would potentially limit reinforcing effects of cigarettes. We conducted 2...