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  1. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 012

    Equivalence testing in demonstrating substantial equivalence for new tobacco products

    FROST-PINEDA K.(1); CAMPBELL L.R.(1); POLSTER M.(2); CURTIN G.M.(1)
    (1) RAI Services Company, Winston Salem, NC, USA; (2) Naxion, Philadelphia, PA, USA
    Under Section 905j of the Tobacco Control Act, manufacturers must submit reports to the FDA to demonstrate that a new tobacco product is substantially equivalent (SE) to a “predicate product.” Demonstrating equivalence with traditional statistical ...