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 TOCAT (Category of Tobacco Product ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
to.xpt
to.xpt
Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOPARMCD
TOPARM
TOCAT
TOVAL
TOVALU
1
TOB17
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
9
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. 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.
pd.xpt
pd.xpt
Row
STUDYID
DOMAIN
SPTOBID
PDSEQ
PDPARMCD
PDPARM
PDVALTRG
PDVALMIN
PDVALMAX
PDVALU
1
TOB17
PD
SNUS-77
1
TOCUTSIZ
Tobacco Cut Size
70
65
75
cuts/in
2
TOB17
PD
SNUS-77
1
TOPRTSIZ
Tobacco Particle Size
70
65
75
mm
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 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.