Premarket human studies include human laboratory and clinical studies on product abuse liability associated with the pharmacology of the drug. Integral selleck chemicals Alisertib in the premarket assessment of tobacco product uptake and use is consumer perception and response to the product design, sensory effects, additives, marketing, and promotion, which will determine the extent of product appeal. In addition, consumer perception testing is critical to determine whether any claims of reduced exposure or reduced health risks, marketing efforts, or packaging of the modified risk product are misleading to the consumer regarding the actual risks or benefits associated with the product’s use. Any misleading information may unduly lead to uptake of a product due to erroneous beliefs about the relative health risk of a product.

Postmarket studies are aimed at examining actual population effects. They can include long-term clinical trials with the product to assess health effects, epidemiological studies such as longitudinal case-control cohort or cross-sectional studies of the product (which can assess users, nonusers, and users of other tobacco products), and postmarketing surveillance (which can assess any unanticipated consequences and uptake among nonusers, quitters of tobacco products, or among those who were ready to quit). Consumer perception assessment is again important to determine if, once the product is out on the market, perception of the product differs significantly from the premarket assessments. Inherent in conducting these product evaluation studies is the need to consider person (e.

g., dependence, gender, age, ethnic-racial differences) and other (e.g., price, smoking restrictions, accessibility) factors that may moderate the abuse liability, consumer perception of the product and product use, and consequent toxicant exposure. Each product evaluation area will require an assessment of whether the product leads to significantly reduced risk, similar risk, or increased risk compared with currently marketed tobacco products or other comparator products. Additionally, the likely impact of introducing these products to the population as a whole, including their impact on initiation and cessation, needs to be determined. Research Opportunities The questions associated with modified risk product evaluation are significant in number and scope.

More detailed information on existing methods for testing and research opportunities has also been described elsewhere (Carter et al., 2009; Hanson, O��Connor, & Hatsukami, 2009; Hatsukami et al., 2009; Johnson, Schilz, Djordjevic, AV-951 Rice, & Shields, 2009; O��Connor et al., 2009; Rees, Kreslake, Cummings, et al., 2009; Rees, Kreslake, O��Connor, et al., 2009). It is important to note that not all these questions need to be addressed by research prior to the implementation of regulatory actions (Samet, McMichael, & Wilcox, 2010).