SDTM Example. Cigarette Design Parameters

Tobacco domains

DI = TO for Tobacco Product Identifier

SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier

DO/DU = Tobacco Design Parameters (DP)

LB = Tobacco Product Testing (TT)

This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Cigarette. There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Products (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.

SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???

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The Tobacco Product Design Parameters (DP) is (similar to the Device Properties (DO) domain) represents properties of the tobacco product as used. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer (tobacco researcher) wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TTTESTCD/TTTEST.

Rows 1-4:	Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference.
Row 5:	Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1
Row 6:	Shows the characterizing flavor is menthol for this package of cigarettes.
Row 7:	Shows the heat source is xxx.

dp.xpt

Row	STUDYID	DOMAIN	SPTOBID	DPSEQ	DPTESTCD	DPTEST	DPCAT	DPSCAT	DPCOLSRT
1	TOB07	DP	CIG01a	1	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	TARGET
2	TOB07	DP	CIG01a	2	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	MINIMUM
3	TOB07	DP	CIG01a	3	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	MAXIMUM
4	TOB07	DP	CIG01a	4	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	TARGET
5	TOB07	DP	CIG01a	5	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	MINIMUM
6	TOB07	DP	CIG01a	6	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	MAXIMUM
7	TOB07	DP	CIG01a	7	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	TARGET
8	TOB07	DP	CIG01a	8	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	MINIMUM
9	TOB07	DP	CIG01a	9	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	MAXIMUM
10	TOB07	DP	CIG01a	10	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	TARGET
11	TOB07	DP	CIG01a	11	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	MINIMUM
12	TOB07	DP	CIG01a	12	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	MAXIMUM
13	TOB07	DP	CIG01a	13	TOCUTSIZ	Tobacco Cut Size		mm or cuts per inch ²	TARGET
14	TOB07	DP	CIG01a	14	TOCUTSIZ	Tobacco Cut Size		mm or cuts per inch ²	MINIMUM
15	TOB07	DP	CIG01a	15	TOCUTSIZ	Tobacco Cut Size		mm or cuts per inch ²	MAXIMUM
16	TOB07	DP	CIG01a	16	FLTRVENT	Filter Ventilation		%	TARGET
17	TOB07	DP	CIG01a	17	FLTRVENT	Filter Ventilation		%	MINIMUM
18	TOB07	DP	CIG01a	18	FLTRVENT	Filter Ventilation		%	MAXIMUM
19	TOB07	DP	CIG01a	19	TPNPLGTH	Tipping Paper Length		mm	TARGET
20	TOB07	DP	CIG01a	20	TPNPLGTH	Tipping Paper Length		mm	MINIMUM
21	TOB07	DP	CIG01a	21	TPNPLGTH	Tipping Paper Length		mm	MAXIMUM
22	TOB07	DP	CIG01a	22	CIGBPPOR	Cigarette Base Paper Porosity or Permeability		CORESTA Unit (Cu)	TARGET
23	TOB07	DP	CIG01a	23	CIGBPPOR	Cigarette Base Paper Porosity or Permeability		CORESTA Unit (Cu)	MINIMUM
24	TOB07	DP	CIG01a	24	CIGBPPOR	Cigarette Base Paper Porosity or Permeability		CORESTA Unit (Cu)	MAXIMUM
25	TOB07	DP	CIG01a	25	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity		CORESTA Unit (Cu) or cm²/s	TARGET
26	TOB07	DP	CIG01a	26	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity		CORESTA Unit (Cu) or cm²/s	MINIMUM
27	TOB07	DP	CIG01a	27	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity		CORESTA Unit (Cu) or cm²/s	MAXIMUM
28	TOB07	DP	CIG01a	28	CPBNDWID	Cigarette Paper Band Width		mm	TARGET
29	TOB07	DP	CIG01a	29	CPBNDWID	Cigarette Paper Band Width		mm	MINIMUM
30	TOB07	DP	CIG01a	30	CPBNDWID	Cigarette Paper Band Width		mm	MAXIMUM
31	TOB07	DP	CIG01a	31	CPBNDSPC	Cigarette Paper Band Space		mm	TARGET
32	TOB07	DP	CIG01a	32	CPBNDSPC	Cigarette Paper Band Space		mm	MINIMUM
33	TOB07	DP	CIG01a	33	CPBNDSPC	Cigarette Paper Band Space		mm	MAXIMUM
34	TOB07	DP	CIG01a	34	FLTREFF	Filter Efficiency		%	TARGET
35	TOB07	DP	CIG01a	35	FLTREFF	Filter Efficiency		%	MINIMUM
36	TOB07	DP	CIG01a	36	FLTREFF	Filter Efficiency		%	MAXIMUM
37	TOB07	DP	CIG01a	37	DPF	Denier Per Filament		/filament	TARGET
38	TOB07	DP	CIG01a	38	DPF	Denier Per Filament		/filament	MINIMUM
39	TOB07	DP	CIG01a	39	DPF	Denier Per Filament		/filament	MAXIMUM
40	TOB07	DP	CIG01a	40	DENIER	Denier		g/9000 m	TARGET
41	TOB07	DP	CIG01a	41	DENIER	Denier		g/9000 m	MINIMUM
42	TOB07	DP	CIG01a	42	DENIER	Denier		g/9000 m	MAXIMUM
43	TOB07	DP	CIG01a	43	FLTRDEN	Filter Density		g/cm³	TARGET
44	TOB07	DP	CIG01a	44	FLTRDEN	Filter Density		g/cm³	MINIMUM
45	TOB07	DP	CIG01a	45	FLTRDEN	Filter Density		g/cm³	MAXIMUM
46	TOB07	DP	CIG01a	46	FLTRLGTH	Filter Length		mm	TARGET
47	TOB07	DP	CIG01a	47	FLTRLGTH	Filter Length		mm	MINIMUM
48	TOB07	DP	CIG01a	48	FLTRLGTH	Filter Length		mm	MAXIMUM
49	TOB07	DP	CIG01a	49	FLTPRDRP	Filter Pressure Drop		mm H2O	TARGET
50	TOB07	DP	CIG01a	50	FLTPRDRP	Filter Pressure Drop		mm H2O	MINIMUM
51	TOB07	DP	CIG01a	51	FLTPRDRP	Filter Pressure Drop		mm H2O	MAXIMUM
52	TOB07	DP	CIG01a	52	TORODDEN	Tobacco Rod Density		g/cm³	TARGET
53	TOB07	DP	CIG01a	53	TORODDEN	Tobacco Rod Density		g/cm³	MINIMUM
54	TOB07	DP	CIG01a	54	TORODDEN	Tobacco Rod Density		g/cm³	MAXIMUM
55	TOB07	DP	CIG01a	55	Cigarette Paper Length	CIGPLGTH		mm	TARGET
56	TOB07	DP	CIG01a	56	Cigarette Paper Length	CIGPLGTH		mm	MINIMUM
57	TOB07	DP	CIG01a	57	Cigarette Paper Length	CIGPLGTH		mm	MAXIMUM

Dataset Debug Messages

There is a leading, trailing, or non-breaking space in the dataset.
Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Rows 1-4:
Row 5:	S
Row 6:
Row 7:

Row Captions Debug Message

Please provide a caption for every row caption label.

tt.xpt

Row	STUDYID	DOMAIN	SPTOBID	TTSEQ	TTTEST	TTORRESU	TTSTRESU
1	TOB07	TT	CIG01a	1	Tobacco Filler mass	mg	mg
2	TOB07	TT	CIG01a	2	Tobacco moisture or Oven Volatiles	%	%
3	TOB07	TT	CIG01a	3	Tobacco cut size	mm or cuts per inch ²	mm or cuts per inch ²
4	TOB07	TT	CIG01a	4	Tobacco Rod density	g/cm³	g/cm³
5	TOB07	TT	CIG01a	5	Filter Ventilation	%	%
6	TOB07	TT	CIG01a	6	Cigarette base paper Porosity or Permeability	CORESTA Unit (Cu)	CORESTA Unit (Cu)
7	TOB07	TT	CIG01a	7	Cigarette Paper band porosity or permeability or band diffusivity	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s
8	TOB07	TT	CIG01a	8	Filter efficiency¹	%	%
9	TOB07	TT	CIG01a	9	Denier per Filament	DPF	DPF
10	TOB07	TT	CIG01a	10	Total Denier	g/9000 m	g/9000 m
11	TOB07	TT	CIG01a	11	Filter Density	g/cm³	g/cm³
12	TOB07	TT	CIG01a	12	Filter Pressure Drop	mm H2O	mm H2O

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

This images shows the filtration zone where the ventilation occurs.

Question - is this helpful? Will need permission. This is from the second reference.

References:

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SDTM Example. Cigarette Design Parameters