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Tobacco products: principles for designing and conducting tobacco product perception and intention studies
Tobacco products: principles for designing and conducting tobacco product perception and intention studies
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Tobacco Products (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Tobacco Products, August 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Evaluation Studies as Topic
Government Regulation
Methods
Tobacco Products
United States
United States. Food and Drug Administration - Genre(s):
- Guideline
Technical Report - Abstract:
- This guidance document is intended to help applicants (or “you”) design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).2 TPPI studies are studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products. It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this guidance. This guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications: (1) Developing TPPI study aims and hypotheses (2) Designing quantitative and qualitative TPPI studies (3) Selecting and adapting measures of TPPI study constructs (4) Determining TPPI study outcomes (5) Selecting and justifying TPPI study samples (6) Analyzing TPPI study results FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required. This guidance provides non-binding recommendations on TPPI studies and does not establish requirements for submitting studies in support of an application.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 22 pages))
- NLM Unique ID:
- 9918486676006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486676006676