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. |