You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 20 Next »

This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST)

This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product SNUS. 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 product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. 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, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.


Rows 1-4:Show the records for a tobacco product given SPTOBID of the Smokeless Tobacco Product, portioned SNUS.
Rows 1-3:Show the tobacco product is Joes Smokeless, Happy Dog Snus.
Rows 5-11:Show the package type is a Plastic Can and Plastic Lid that is a package of 24 with a portion mass of 1g each. in 30 mm x 10 mm x 5 mm cans.
Rows 12-13:Show the attributes or characteristics of the content of the SNUS.

to.xpt

to.xpt

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 DESCRIPTOR24eaches or blank? - EACH?
9TOB17TOSNUS-779PRTLENGPortion lengthPRODUCT DESCRIPTOR30mm
10TOB17TOSNUS-7710PRTWDTHPortion widthPRODUCT DESCRIPTOR10mm
11TOB17TOSNUS-7711PRTTHICKPortion thicknessPRODUCT DESCRIPTOR5mm
12TOB17TOSNUS-7712CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMint
13TOB17TOSNUS-7713ADDPROPAdditional propertyPRODUCT DESCRIPTORn/a
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

Rows 1-27:Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.
Rows 7-18:Show the design parameter specification for portioned characteristics.

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB17

PDSNUS-77

1


Tobacco Cut Size or Tobacco Particle Size

70

65

75

mm or cuts per inch

2TOB17PDSNUS-772
Tobacco Moisture32.23134%
3TOB17PDSNUS-773
Portion Length3836.539.5mm
4TOB17PDSNUS-774
Portion Width161517mm
5TOB17PDSNUS-775
Portion Mass10009001100mg
6TOB17PDSNUS-776
Portion (pouch) material thickness (if applicable)0.060.0550.065mm
7TOB17PDSNUS-777
Pouch material basis weight (if applicable)161517g/m^2
8TOB17PDSNUS-778
Pouch material porosity (permeability) (if applicable)185016002200L/m^2/s
9TOB17PDSNUS-779
Nicotine dissolution rate


%/min
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) 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).

**For  Pouch material porosity - which one should be the standard result?

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.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTREPNUMPTTPTPTTPTNUM
1TOB17PTSNUS-771

Tobacco Cut Size or Tobacco Particle Size
DESIGN PARAMETER TESTING

70

mm or cuts per inch

70

70

mm or cuts per inch1Week 01
2TOB17PTSNUS-772

Tobacco Moisture
DESIGN PARAMETER TESTING
31.8%31.831.8%1Week 01
3TOB17PTSNUS-773

Portion Mass
DESIGN PARAMETER TESTING
998mg998998mg1Week 01
4TOB17PTSNUS-774

Pouch material basis weight
DESIGN PARAMETER TESTING
15.3g/m^215.315.3g/m^21Week 01
5TOB17PTSNUS-775

Pouch material porosity (permeability)
DESIGN PARAMETER TESTING
1900L/m^2/s19001900L/m^2/s1Week 01
6TOB17PTSNUS-776

Nicotine dissolution rate
DESIGN PARAMETER TESTING

%/min

%/min1Week 01
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

  • No labels