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Clinical Trials involving a tobacco product may include assessments of pattern of product use, extent of exposure to toxicants and biological effect, abuse potential and consumer perception of the product. Studies may examine nicotine pharmacokinetics, subjective and physiological responses and biomarkers of exposure. These studies types include abuse liability studies, in-laboratory clinical trials (subject uses the product once or a few times, but only in a laboratory setting), short-term clinical trials (<2 weeks of duration on a particular product), or intermediate-term clinical trials (> 2 weeks and ≤ 12 months.
These DA and receive a marketing authorization from FDA. When a new tobacco product
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All studies,
including studies on tobacco products, collect general information about a subject/participant. This section shows information typically collected in all studies, such as study disposition, demographic and subject characteristic information ( e.g., sex, age), information about prior tobacco product use, safety laboratory tests, and medical history. Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings.Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-160
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