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Tobacco product stability study Tobacco product HPHC testing results are represented in the PT . These are just the data that show the testing results under specific storage conditions domain. This example illustrates HPHC testing and smoking regimens for a cigarette product. The details of the regimen and storage conditions are shown in separate datasets that follow this example.

• The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
• The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
• The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
• We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.

https://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example.

https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345 

The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product. example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See Section 3.1.4, Stability Studies, for more information and examples illustrating how to represent those data.

This example only shows test results for each constituent for one 1 replicate of 1 sample of one 1 product that was tested . The sampling plan (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor. In reality, sponsors would applicant or by regulatory requirement.  Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset . These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.         by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.

Note the use of the PTXFN (external file name) to indicate that the lab methodology was submitted as separate documentation.