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

Nonclinical studies are conducted in tobacco product research to assess health risks

, toxicological, pharmacological, and behavioral impacts tobacco products and their constituents have within in vitro and in vivo for 

Nonclinical studies tobacco product studies are conducted in vitro and in vivo to assess the biological, toxicological, 

In general, nonclinical studies can inform clinical studies by 

For example constituents, including HPHCs and other toxicants,  health risks/

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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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