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Tobacco product stability is assessed to ensure products are as expected with regard to their stabilities are conducted to assess changes in the properties, characteristics, and constituents of a product over the course of the product's shelf - life after manufacture. Any changes of a product over time may affect the health risks of product use.
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Measures of stability may include : microbial stability
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, chemical stability
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, product component stability (
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e.
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g., battery)
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, and container closure stability (
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e.
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g., leachability)
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.
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Stability studies of tobacco products would typically require testing for constituents and parameters in multiple replicates over multiple timepoints throughout a study, and possibly under multiple different sets of storage conditions. Such studies result in datasets that can be quite large. In order to demonstrate the concepts in more concise datasets, the SDTM examples here illustrates stability studies in 2 parts: (1) a dataset that shows results from testing of multiple constituents at 1 replicate, 1 timepoint, under 1 set of environmental storage conditions; and (2) a dataset that shows what the results would look like for testing of 1 constituent at 3 replicates, 3 timepoints, and 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 demonstrates stability studies using constituents/parameters applicable to a smokeless tobacco product.
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