The following example illustrates the representation of smokeless tobacco product design parameter specifications using the PD domain. First, the TO example below shows the identifiers and descriptors associated with this productNote that this example makes use of TOCAT (Category of Tobacco Product ID Element, a permissible variable) to emphasize and differentiate the two different 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. |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOVAL | TOVALU |
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1 | | TO | SNUS-77 | 1 | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | Smokeless Tobacco Product |
| 2 | TOB17 | TO | SNUS-77 | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Snus, portioned |
| 3 | TOB17 | TO | SNUS-77 | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | Joes Smokeless |
| 4 | TOB17 | TO | SNUS-77 | 4 | TRADENAM | Trade Name | PRODUCT IDENTIFIER | Happy Dog Snus |
| 5 | TOB17 | TO | SNUS-77 | 5 | PACKTYP | Package Type | PRODUCT DESCRIPTOR | Plastic can and plastic lid |
| 6 | TOB17 | TO | SNUS-77 | 6 | PACKQUAN | Package Quantity | PRODUCT DESCRIPTOR | 24 | g | 7 | TOB17 | TO | SNUS-77 | 7 | PORTMASS | Portion Mass | PRODUCT DESCRIPTOR | 1 | g | 8 | TOB17 | TO | SNUS-77 | 8 | PORTCONT | Portion count | PRODUCT DESCRIPTOR | 24 |
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| TO | SNUS-77 | 9 | PRTLENG | Portion length | PRODUCT DESCRIPTOR | 30 | mm | 10 | TOB17 | TO | SNUS-77 | 10 | PRTWDTH | Portion width | PRODUCT DESCRIPTOR | 10 | mm | 11 | TOB17 | TO | SNUS-77 | 11 | PRTTHICK | Portion thickness | PRODUCT DESCRIPTOR | 5 | mm | 12 | TOB17 | TO | SNUS-77 | 12 | CHARFLAV | Characterizing Flavor | PRODUCT DESCRIPTOR | Mint |
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The manufacturing parameter specifications of the tobacco product as used are represented in 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.. The 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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The Finally, 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)domain is used to represent the actual results of testing the manufactured product for conformance to the tobacco product design parameters shown in PD above. 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 one 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 | 1 | Week 0 | 1 | 3 | TOB17 | PT | SNUS-77 | 2 | TOMOISTR | Tobacco Moisture | DESIGN PARAMETER TESTING | 31.8 | % | 31.8 | 31.8 | % | 1 | Week 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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