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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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Nameto
Rowcaps
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
RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOVALTOVALU
1

TOB17

TOSNUS-771TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERSmokeless Tobacco Product
2TOB17TOSNUS-772TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERSnus, portioned
3TOB17TOSNUS-773MANUFManufacturerPRODUCT IDENTIFIERJoes Smokeless
4TOB17TOSNUS-774TRADENAMTrade NamePRODUCT IDENTIFIERHappy Dog Snus
5TOB17TOSNUS-775PACKTYPPackage TypePRODUCT DESCRIPTORPlastic can and plastic lid
6TOB17TOSNUS-776PACKQUANPackage QuantityPRODUCT DESCRIPTOR24g
7TOB17TOSNUS-777PORTMASSPortion MassPRODUCT DESCRIPTOR1g
8TOB17TOSNUS-778PORTCONTPortion countPRODUCT DESCRIPTOR24
9
TOSNUS-779PRTLENGPortion lengthPRODUCT DESCRIPTOR30mm
10TOB17TOSNUS-7710PRTWDTHPortion widthPRODUCT DESCRIPTOR10mm
11TOB17TOSNUS-7711PRTTHICKPortion thicknessPRODUCT DESCRIPTOR5mm
12TOB17TOSNUS-7712CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMint

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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Namepd
Dataset2
RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB17

PDSNUS-77

1

TOCUTSIZTobacco Cut Size

70

65

75

cuts/in

2

TOB17

PDSNUS-77

1

TOPRTSIZTobacco Particle Size

70

65

75

mm

3TOB17PDSNUS-772TOMOISTRTobacco Moisture32.23134%
4TOB17PDSNUS-773PRTLENGPortion Length3836.539.5mm
5TOB17PDSNUS-774PRTWDTHPortion Width161517mm
6TOB17PDSNUS-775PRTMASSPortion Mass10009001100mg
7TOB17PDSNUS-776PRTTHICKPortion Material Thickness0.060.0550.065mm
8TOB17PDSNUS-777PRTMWGTPouch Material Basis Weight161517g/m2
9TOB17PDSNUS-778PRTMPORPouch Material Porosity185016002200L/m2/s
10TOB17PDSNUS-779NICTDSRTNicotine Dissolution Rate15522%/min

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.

Rows 1-6:
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Namept
Rowcaps
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.
Dataset2
RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTREPNUMPTTPTPTTPTNUM
1TOB17PTSNUS-771TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING

70

cuts per inch

70

70

cuts/in1Week 01
2TOB17PTSNUS-771TOPRTSIZTobacco Particle SizeDESIGN PARAMETER TESTING

70

mm

70

70

mm1Week 01
3TOB17PTSNUS-772TOMOISTRTobacco MoistureDESIGN PARAMETER TESTING31.8%31.831.8%1Week 01
4TOB17PTSNUS-773PRTMASSPortion MassDESIGN PARAMETER TESTING998mg998998mg1Week 01
5TOB17PTSNUS-774PRTMWGTPouch Material Basis WeightDESIGN PARAMETER TESTING15.3g/m215.315.3g/m21Week 01
6TOB17PTSNUS-775PRTMPORPouch Material PorosityDESIGN PARAMETER TESTING1900L/m2/s19001900L/m2/s1Week 01
7TOB17PTSNUS-776NICTDSRTNicotine Dissolution RateDESIGN PARAMETER TESTING18%/min1818%/min1Week 01