The following example illustrates the representation of a smokeless tobacco product design parameter specifications 's (portioned snus) identifiers and descriptors using the PD TO domain. First, the TO example below shows the identifiers and descriptors associated with this productNote that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
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Rows 1-4: | Show the identifying characteristics of a Smokeless Tobacco Product, portioned snus. |
Rows 5-12: | Show additional descriptors of the portioned snus product. | Dataset2 |
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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 | Mint | Flavored |
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The manufacturing parameter specifications of the portioned snus tobacco product as intended for use are represented in the PD domain. The following example 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. The Product Design Parameters (PD) domain is used to represent design specification parameters of the tobacco product. Each property is identified using controlled terminology and is stored in PDPARMCD/PDPARM. Note the use of PDCAT (category) to distinguish between product identifiers and other descriptors of the product.
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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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The Tobacco Product Testing (PT) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset)Finally, the 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. PTCAT is a 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 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.
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Rows 1-6: | Show the tobacco design parameter specification test and the result in ORRES for the SNUS. (needs populated). |
Row 3: | Shows the design parameter specification for the portion mass.
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Row | STUDYID | DOMAIN | SPTOBID | PTSEQPTREFID | PTTESTCD | PTTEST | PTTSTCND | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB17 | PT | SNUS-77 | 1 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER TESTING | | cuts per inch | | | cuts/in | 1 | Week 0 | 1 | 2 | TOB17 | PT | SNUS-77 | 1 | TOPRTSIZ | Tobacco Particle Size | DESIGN PARAMETER TESTING | | mm | | | mm | 1Week 0 | 1 | 3 | TOB17 | PT | SNUS-77 | 2 | TOMOISTR | Tobacco Moisture | DESIGN PARAMETER TESTING | 31.8 | % | 31.8 | 31.8 | % | 1Week 0 | 1 | 4 | TOB17 | PT | SNUS-77 | 3 | PRTMASS | Portion Mass | DESIGN PARAMETER TESTING | 998 | mg | 998 | 998 | mg | 1 | Week 0 | 1 | 5 | TOB17 | PT | SNUS-77 | 4 | PRTMWGT | Pouch Material Basis Weight | DESIGN PARAMETER TESTING | 15.3 | g/m2 | 15.3 | 15.3 | g/m2 | 1 | Week 0 | 1 | 6 | TOB17 | PT | SNUS-77 | 5 | PRTMPOR | Pouch Material Porosity | DESIGN PARAMETER TESTING | 1900 | L/m2/s | 1900 | 1900 | L/m2/s | 1 | Week 0 | 1 | 7 | TOB17 | PT | SNUS-77 | 6 | NICTDSRT | Nicotine Dissolution Rate | DESIGN PARAMETER TESTING | 18 | %/min | 18 | 18 | %/min | 1 | Week 0 | 1 |
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