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Nonclinical tobacco product studies are conducted in tobacco product research to assess biological activity within biological systems and to identify toxicity and genotoxicity related to the products.

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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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