Tobacco product stabilities are conducted to assess changes in the properties, characteristics and constituents of a product over the course of the shelf-life after manufacture. Any changes of a product over time may affect the health risks of product use.
Measures of stability may include microbial stability, chemical stability, product component stability (i.e. battery), container closure stability (i.e. leachability), etc.
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 studies will result in datasets that 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 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 ADaM standard.
Example
The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the Tobacco Product Testing (PT) domain, with PTCAT = STABILITY TESTING.
The first pt.xpt dataset shows 22 consituents and 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. Some constituent names (values of PTTESTCD/PTTEST) appear twice because they are tested separately in both e-liquid and aerosol (as indicated by PTSPEC). Note that the constituent names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.
- The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (shown in SPDEVID) was used to perform the vaping regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.2, HPHCs, Other Constituents, and Smoking / Vaping Regimens.
- 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 when such methodology is too complex for the single PTMETHOD variable.
- 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 Environmental Storage Conditions (ES) dataset example that follows the 2 PT dataset examples.
- In this example, the applicant chose to subcategorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The second PT dataset shows testing for just 1 constituent (nicotine), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 3 sets of storage conditions (STOCONID), in samples of e-liquid and aerosol (PTSPEC) in order to illustrate how those variables are used to represent their associated concepts in a stability study.
- As in the first PT dataset, the details of the smoking machine and vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens.
- Details of the 3 conditions are represented in the ES dataset example that follows.
Details of the storage conditions are represented in the 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 all 3 sets of storage conditions used across both of the PT dataset examples.
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
Please add a row column to your dataset.
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.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
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 |
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