Page History

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 result in datasets that can be quite large. In order to demonstrate the concepts in more concise datasets, the two SDTM examples below illustrate 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 example 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.