The following example illustrates the representation of a smokeless tobacco product's (portioned snus) identifiers and descriptors using the TO domain. Note that this example makes use of TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) uses TOSCAT to emphasize and differentiate the two 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOSCAT | TOVAL | TOVALU |
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1 | | TO | SNUS-77 | 1 | TBPRDCAT | Tobacco Product Category | NEW PRODUCT | PRODUCT IDENTIFIER | Smokeless Tobacco ProductProducts |
| 2 | TOB17 | TO | SNUS-77 | 2 | TBPRSCAT | Tobacco Product Subcategory | NEW PRODUCT | PRODUCT IDENTIFIER | Portioned Snus, portioned |
| 3 | TOB17 | TO | SNUS-77 | 3 | MANUF | Manufacturer | NEW PRODUCT | PRODUCT IDENTIFIER | Joes Smokeless |
| 4 | TOB17 | TO | SNUS-77 | 4 | TRADENAM | Trade Name | NEW PRODUCT | PRODUCT IDENTIFIER | Happy Dog Snus |
| 5 | TOB17 | TO | SNUS-77 | 5 | PACKTYP | Package Type | NEW PRODUCT | PRODUCT DESCRIPTOR | Plastic can and plastic lidCan with Lid |
| 6 | TOB17 | TO | SNUS-77 | 6 | PACKQUAN | Package Quantity | NEW PRODUCT | PRODUCT DESCRIPTOR | 24 | g | 7 | TOB17 | TO | SNUS-77 | 7 | PORTMASSPRTMASS | Portion Mass | NEW PRODUCT | PRODUCT DESCRIPTOR | 1 | g | 8 | TOB17 | TO | SNUS-77 | 8 | PORTCONT | Portion count | NEW PRODUCT | PRODUCT DESCRIPTOR | 24 |
| 9 | TOB17 | TO | SNUS-77 | 9 | PRTLENG | Portion length | NEW PRODUCT | PRODUCT DESCRIPTOR | 30 | mm | 10 | TOB17 | TO | SNUS-77 | 10 | PRTWDTH | Portion width | NEW PRODUCT | PRODUCT DESCRIPTOR | 10 | mm | 11 | TOB17 | TO | SNUS-77 | 11 | PRTTHICK | Portion thickness | NEW PRODUCT | PRODUCT DESCRIPTOR | 5 | mm | 12 | TOB17 | TO | SNUS-77 | 12 | CHARFLAV | Characterizing Flavor | NEW PRODUCT | PRODUCT DESCRIPTOR | MintFlavored |
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The manufacturing parameter specifications of the portioned snus tobacco product as intended for use are represented in the Product Design Parameters ( PD ) domain. The following example below shows the target, minimum, and maximum values associated with each of 10 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.
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Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU |
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1 | | PD | SNUS-77 | | TOCUTSIZ | Tobacco Cut Size | | | | | 2 | | PD | SNUS-77 | | TOPRTSIZ | Tobacco Particle Size | | | | | 3 | TOB17 | PD | SNUS-77 | 2 | TOMOISTR | Tobacco Moisture | 32.2 | 31 | 34 | % | 4 | TOB17 | PD | SNUS-77 | 3 | PRTLENG | Portion Length | 38 | 36.5 | 39.5 | mm | 5 | TOB17 | PD | SNUS-77 | 4 | PRTWDTH | Portion Width | 16 | 15 | 17 | mm | 6 | TOB17 | PD | SNUS-77 | 5 | PRTMASS | Portion Mass | 1000 | 900 | 1100 | mg | 7 | TOB17 | PD | SNUS-77 | 6 | PRTTHICK | Portion Material Thickness | 0.06 | 0.055 | 0.065 | mm | 8 | TOB17 | PD | SNUS-77 | 7 | PRTMWGT | Pouch Material Basis Weight | 16 | 15 | 17 | g/m2 | 9 | TOB17 | PD | SNUS-77 | 8 | PRTMPOR | Pouch Material Porosity | 1850 | 1600 | 2200 | L/m2/s | 10 | TOB17 | PD | SNUS-77 | 9 | NICTDSRT | Nicotine Dissolution Rate | 15 | 5 | 22 | %/min |
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Finally, the Tobacco Product Testing ( PT ) domain is used to represent the actual results of testing the manufactured portioned snus product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.
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