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Measures of stability may include microbial stability, chemical stability, product component stability (i.e. battery), container closure stability (i.e. leachability), etc.


Info

Stability studies of tobacco products would typically require testing for constituents and parameters in multiple replicates over multiple timepoints throughout the study, and possibly under multiple different sets of storage conditions. Such datasets can be quite large. In order to demonstrate the concepts in more concise datasets, the two SDTM examples below illustrate stability studies in two parts: 1) a dataset that shows results from testing of multiple constituents at one replicate, one timepoint, under one set of environmental storage conditions, and 2) a dataset example that shows what the results would look like for testing of ONE constituent at three replicates, three timepoints, and two different sets of storage conditions. The examples demonstrate these concepts for a smokeless tobacco product (Example 1) and and ENDS 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 ADaM standard.

Example

Include Page
SDTM Example.Stability Study for Smokeless Tobacco Products
SDTM Example.Stability Study for Smokeless Tobacco Products

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