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Smoking/Vaping vaping puff topography is how the a smoker smokes /or vapes a tobacco product. Measures of vaping/smoking behavior is critical to understand exposures understanding exposure to biomarkers of nicotine exposure and toxins. There are topography Topography devices that are used to measure cigarette and e-cigarette puffing behavior, these devices may also be used evaluate electronic cigarette use. There are also calibrated laboratory-based smoking puff analyzer devices that are combined with an analytical smoking machine that generates programmable puffs with high precision. Puff , inhalation and exhalation duration; , puff volume; , and inter-puff interval are often measured. Sponsors may find information in a Technical Document has been published on the CORESTA website (Oct 2022): Assessing Product Use Behaviour and Exposure: Definitions and Methods

Puff topography is typically considered data about the subject's exposure to the test product. As these data represent information about study product exposure, the data is represented in the Exposure (EX) domain . More information on the Exposure domain is found here. Exposure Assessments During a Trial (see Section 3.3.4, Exposure Assessments During Tobacco Product Studies).

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Puff topography is often measured using Smoking Machinessmoking machines. Information about Devices are devices—not the study subject nor the study itself—are represented using the SDTM Medical Devices Domain.  These domains represent information about devices and not study subject or the trial itself.Device domains. 

Example

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SDTM Example.Puff Topogaphy
SDTM Example.Puff Topogaphy

Reference:

CORESTA. Assessing Product Use Behaviour and Exposure: Definitions and Methods. October 2022. Accessed October 17, 2023. https://www.coresta.org/assessing-product-use-behaviour-and-exposure-definitions-and-methods-36737.html


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