Tobacco product stability is assessed to ensure products are as expected with regard to their properties, characteristics and constituents 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.
- Finished product stability studies - most common. This may include aspects of:
- raw materials stability studies - mention, but not focus
- bulk e-liquid stability studies - mention, but not focus
Measures of stability may include:
- microbial stability
- chemical stability
- product component stability (i.e. battery)
- container closure stability (i.e. leachability)
- shelf life and storage
Example
The first PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because their results are reported two separate ways: once for the result as tested and once where the result is expressed as dry weight basis (the latter is indicated by PTTSTDTL = DRY WEIGHT BASIS). Note that the constituent/parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.
- STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the 2 PT dataset examples.
- PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent/parameter when such methodology is too complex for the single PTMETHOD variable.
Dataset Wrapper Debug Message
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The second PT dataset shows testing for just 1 parameter (Moisture Content), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study.
- Details of the storage conditions are represented in the ES dataset example that follows.
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Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The ES dataset shows both sets of storage conditions used across both of the PT dataset examples.
Example
The following example illustrates calculation of some of the statistics typically calculated on product stability measures.
ADPT Dataset Metadata
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|---|---|---|---|---|---|---|
| ADPT | Product Stability Analysis Dataset | ADAM OTHER | one record per product stability identifier per parameter qualifier per parameter per analysis timepoint | Analysis | PRODSTID, PARQUAL, PARAM, ATPT | adpt.xpt | NA |
ADPT Variable Metadata
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | Char | Req | PT.STUDYID | |
| PRODSTID | Product Stability Identifier | Char | Req | Concatenate SPTOBID with STOCONID separated with '/' | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Perm | PT.SPTOBID | |
| STOCONID | Applicant-Defined Storage Conditions ID | Char | Perm | PT.STOCONID | |
| PARQUAL | Parameter Qualifier | Char | Cond | Set to the item being tested | |
| PARAM | Parameter | Char | Req | Set to the parameter being captured | |
| PARAMCD | Parameter Code | Char | Req | Set to the parameter code associated with the parameter | |
| AVAL | Analysis Value | Num | Req | Calculated statistic | |
| ATPT | Analysis Timepoint | Char | Cond | PT.PTTPT | |
| ATPTN | Analysis Timepoint (N) | Num | Cond | PT.PTTPTNUM |
Overview
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