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Tobacco product stabilities are conducted to assess changes in the properties, characteristics, and constituents of a product over the course of the shelf - life after manufacture. Any changes of a product over time may affect the health risks of product use.
Measures of stability may include microbial stability, chemical stability, product component stability (ie.eg., battery), and container closure stability (ie.eg., leachability), etc.
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Stability studies of tobacco products would typically require testing for constituents and parameters in multiple replicates over multiple timepoints throughout the a study, and possibly under multiple different sets of storage conditions. Such studies will result in datasets that can be quite large. In order to demonstrate the concepts in more concise datasets, each of the two SDTM examples below here illustrates stability studies in two 2 parts: (1) a dataset that shows results from testing of multiple constituents at one 1 replicate, one 1 timepoint, under one 1 set of environmental storage conditions, ; and (2) a dataset that shows what the results would look like for testing of one 1 constituent at three 3 replicates, three 3 timepoints, and two 2different sets of storage conditions. The examples demonstrate these concepts for an ENDS tobacco product (Example 1) and a smokeless tobacco product (Example 2). Additionally, an analysis dataset example is provided for the smokeless tobacco product to illustrate the representation of some common statistics using the CDISC ADaM standard. |
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Example 2 , below, demonstrates stability studies using constituents/parameters applicable to a smokeless tobacco product.
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