Nonclinical tobacco product studies are conducted to assess the biological, toxicological, pharmacological, 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 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 (TS, TX domains); and
- additional trial design datasets needed to fully describe in vivo study designs (TA, TE domains)
Overview
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