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Nonclinical tobacco product studies are conducted 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 advice and examples for representing data from nonclinical tobacco product research using the Study Data Tabulation Model ( SDTM), including:

• guidance Guidance on the use of domains and variables;

• examples Examples of SDTM datasets, with text describing the situational context and pointing out records of note; and...
• 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