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Nonclinical tobacco product studies are conducted in tobacco product research to demonstrate

• biological activity within biological systems and identify toxicity and genotoxicity related to the products.

To see what kind of toxicity is related to the products

Understanding how tobacco products and changes to tobacco product characteristics* affect their potential to cause morbidity and mortality in both users and secondary exposure; including animal and cell culture models as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke, aerosols, or specific constituents in tobacco. Priorities include:

• Toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class including ENDS, cigars, waterpipes, and smokeless tobacco; 
• How product design characteristics* (variation(s) in those characteristics*) impact constituent exposure and toxicity from tobacco products; 
• Biomarkers to assess exposure, as well as biomarkers to assess harm or toxicity of non-cigarette tobacco products, including ENDS; 
• Toxicological impact of nicotine, flavors, and other constituents across different routes of exposure. 

to assess the biological, toxicological, pharmacological, and behavioral impacts tobacco products and their constituents have within in vitro and in vivo test systems. This section provides examples for representing data from nonclinical tobacco product research using the SDTM, including:

• Guidance on the use of domains and variables

• Examples of SDTM datasets, with text describing the situational context and pointing out records of note
• Descriptions and examples of trial design datasets for use with both in vitro and in vivo studies
• Additional trial design datasets needed to fully describe in vivo study designs

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