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THIS EXAMPLE IS UNDER RECONSTRUCTION FOLLOWING DISCUSSIONS ON THE TEAM CALL 17 JAN. Updates include: 1) Simplifying PD.xpt to one record per parameter and (2), simplifying TO.xpt to a parameter-based dataset |
https://www.sciencedirect.com/science/article/pii/S004060311930752X
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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 Electronic Nicotine Delivery System (ENDS) (Vapes). 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 foundThe following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
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Rows 1-4: | Show the records for a tobacco product given SPTOBID of VAPE-Z27. |
Rows 1-3: | Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette. | Rows 5-8: | Show the package type is a Box that contains 1 E-Cigarette that is 107.2 mm long and 9.0 mm in diameter. | Rows 9-12: | Show the attributes or characteristics of the content of the e-liquid within the E-cigarette. | Rows 13-15: | Show the attributes or characteristics of the heating element for the E-cigarette . | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOSCAT | TOVAL | TOVALU |
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1 | TOB09 | TO | VAPE-Z27 | | TBPRDCAT | Tobacco Product Category | NEW PRODUCT | PRODUCT IDENTIFIER | Electronic Nicotine Delivery Systems (ENDS) ( | VAPESVapes) |
| 2 | TOB09 | TO | VAPE-Z27 | 2 | TBPRSCAT | Tobacco Product Subcategory | NEW PRODUCT | PRODUCT IDENTIFIER | Closed E-Cigarette |
| 3 | TOB09 | TO | VAPE-Z27 | 3 | MANUF | Manufacturer | NEW PRODUCT | PRODUCT IDENTIFIER | Joes Vapes USA |
| 4 | TOB09 | TO | VAPE-Z27 | 4 | TRADENAM | Trade Name | NEW PRODUCT | PRODUCT IDENTIFIER | Everyday Rich Tobacco |
| 5 | TOB09 | TO | VAPE-Z27 | 5 | PACKTYP | Package Type | NEW PRODUCT | PRODUCT DESCRIPTOR | BOX |
| 6 | TOB09 | TO | VAPE-Z27 | 6 | PRDQUAN | Product Quantity | NEW PRODUCT | PRODUCT DESCRIPTOR | 1 | E-CIGARETTE | 7 | TOB09 | TO | VAPE-Z27 | 7 | LENGTH | Length | NEW PRODUCT | PRODUCT DESCRIPTOR | 107.2 | mm | 8 | TOB09 | TO | VAPE-Z27 | 8 | DIAMETER | Diameter | NEW PRODUCT | PRODUCT DESCRIPTOR | 9 | mm | 9 | TOB09 | TO | VAPE-Z27 | 9 | NICTNCNC | Nicotine Concentration | NEW PRODUCT | PRODUCT DESCRIPTOR | 2 | mg/L | 10 | TOB09 | TO | VAPE-Z27 | 10 |
PGVGRT | PG/VG Ratio*PRPYLGLY | Propylene Glycol | NEW PRODUCT | PRODUCT DESCRIPTOR | 50 | /50 | % | 11 | TOB09 | TO | VAPE-Z27 | 11 | VEGGLY |
CHTRFLAV | Vegetable Glycerin | NEW PRODUCT | Characterizing FlavorTOBACCO% | 12 | TOB09 | TO | VAPE-Z27 | 12 | CHARFLAV |
VOLUMEE | Volume, E-liquidCharacterizing Flavor | NEW PRODUCT | PRODUCT DESCRIPTOR | 1mL | WATT | Wattage | ELQDVOL | E-Liquid Volume | NEW PRODUCT | PRODUCT DESCRIPTOR | 5.2WattBATTCAPBATCAPC | Battery Capacity | NEW PRODUCT | PRODUCT DESCRIPTOR | 600 | mAh | 15 | TOB09 | TO | VAPE-Z27 | 15 | DISPCRTGDSCRTIND | Disposable Cartridge Indicator | NEW PRODUCT | PRODUCT DESCRIPTOR | Y |
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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.
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manufacturing parameter specifications of the ENDS product as intended for used are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.
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| value reflected in the PDCOLSRT variable.Rows 80-82: | Show the design parameter specification with the test condition of 20 degrees Celsius using the PDTSTCND variable. |
Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU | PDCOLSRT |
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1 | TOB09 | PD | VAPE-Z27 | | DRWRST | Draw | Resistance Resistance | 90.0 | 80.0 | 120.0 | mm H2O | TARGET | 2 | TOB09 | PD | VAPE-Z27 | 42 | PUFCNT | Puff | count (for full tank/cartridge)Count | 300 | 290 | 310 |
| 7 | 3 | 11 | NUMBER COUNT | TARGET | 3 | TOB09 | PD | VAPE-Z27 | 73 | CRTVOL | Cartridge | volumeVolume | 3 | 1 | 5 | mL | TARGET | 4 | TOB09 | PD | VAPE-Z27 | 104 | HTELNUM | Number of | heating elementsHeating Elements | 1 | 1 | | NUMBER COUNT | TARGET |
| 5 | TOB09 | PD | VAPE-Z27 | 135 | HTELGTH | Heating | element lengthElement Length | 3 | 2.7 | 43.3 | mm | TARGET | 6 | TOB09 | PD | VAPE-Z27 | 166 | HTEDIAM | Heating | element diameterElement Diameter | 3 | 2.9 | 53.2 | mm | TARGET | 7 | TOB09 | PD | VAPE-Z27 | 197 | HTELRST | Heating | element resistanceElement Resistance | 0.75 | 0.25 | 1.5 | ohm | TARGET | 8 | TOB09 | PD | VAPE-Z27 | 228 | HTELRNG | Heating | element rangeElement Range | 175 | 100 | 250 | C | TARGET | 9 | TOB09 | PD | VAPE-Z27 | 259 | HTELCFG | Heating | element configurationElement Configuration | SPIRAL | SPIRAL | SPIRAL | TARGET |
| 10 | TOB09 | PD | VAPE-Z27 | 2610 | BTVLTORG | Battery | voltage operating rangeVoltage Operating Range | 4.5 | 3 | 6 | V | TARGET | 11 | TOB09 | PD | VAPE-Z27 | 2911 | BTCRTORG | Battery | current operating rangeCurrent Operating Range | 1000 | 650 | 1600 | mAh | TARGET | 12 | TOB09 | PD | VAPE-Z27 | 3212 | BATCAPC | Battery | capacityCapacity | 1100 | 800 | 3000 | mAh | TARGET | 13 | TOB09 | PD | VAPE-Z27 | 3513 | BATNOMV | Battery | nominal voltageNominal Voltage | 4.2 | 4.0 | 4.5 | V | TARGET | 14 | TOB09 | PD | VAPE-Z27 | 3814 | BTCRTRT | Battery Current Rating | 2500 | 2000 | 2800 | mA | TARGET | 15 | TOB09 | PD | VAPE-Z27 | 4115 | BTCHTPL | Battery Charging Temperature Limits | 200 | 100 | 315 | C | TARGET | 16 | TOB09 | PD | VAPE-Z27 | 4416 | BTDCTMPL | Battery Discharge Temperature Limits | 20 | -20 | 60 | C | TARGET | 17 | TOB09 | PD | VAPE-Z27 | 4717 | BTENDCV | Battery | end End of | discharge voltageDischarge Voltage | 3.0 | 2.0 | 3.5 | V | TARGET | 18 | TOB09 | PD | VAPE-Z27 | 5018 | BTMXCHC | Battery | maximum charging currentMaximum Charging Current | 24 | 20 | 30 | mA | TARGET | 19 | TOB09 | PD | VAPE-Z27 | 5319 | BTMXDCC | Battery | maximum discharging currentMaximum Discharging Current | 2700 | 2400 | 3000 | mA | TARGET | 20 | TOB09 | PD | VAPE-Z27 | 5620 | BTULCHV | Battery | upper limits charging voltageUpper Limits Charging Voltage | 4.2 | 4.1 | 4.3 | V | TARGET | 21 | TOB09 | PD | VAPE-Z27 | 5921 | PDUVOR | Power Delivery Unit (PDU) voltage operating rangePDU Voltage Operating Range | 3.7 | 3.2 | 4.2 | V | TARGET | 22 | TOB09 | PD | VAPE-Z27 | 6222 | PDUCOR | PDU | current operating rangeCurrent Operating Range | 1200 | 850 | 1800 | mA | TARGET | 23 | TOB09 | PD | VAPE-Z27 | 65 | PDUWTOR | PDU wattage operating range | 75 | 70 | 80 | W | TARGET | 23 | 24 | TOB09 | PD | VAPE-Z27 | 68 | PDUTCTOF | PDU | temperature cutTemperature Cut-off | (if applicable) | 70 | 55 | 65 | C | TARGET 24 | 25 | TOB09 | PD | VAPE-Z27 | 7124 | AIRFLRT | Airflow | rateRate | 720 | 700 | 740 | L/min | TARGET25 | 26 | TOB09 | PD | VAPE-Z27 | 7425 | PDUCRCOF | PDU | current cutCurrent Cut-off | (if applicable) | 35 | 20 | 50 | mA | TARGET | 2726 | TOB09 | PD | VAPE-Z27 | 7726 | INHAERT | Inhaled | aerosol temperatureAerosol Temperature | 37 | 35 | 40 | C | TARGET | 2827 | TOB09 | PD | VAPE-Z27 | 8027 | VENTLTNVENTLTOT | Total Ventilation | 50 | 40 | 60 | % | TARGET | 2928 | TOB09 | PD | VAPE-Z27 | 8328 | ELQDVISC | E-Liquid | viscosity Viscosity | 500 | 75 | 1130 | mPa/s | 29 | TARGET | 30 | TOB09 | PD | VAPE-Z27 | 8629 | ELQDVOL | E-liquid | volumeVolume | 60 | 10 | 120 | mL | TARGET | 3130 | TOB09 | PD | VAPE-Z27 | 8930 | PNUMCNC | Particle | number concentrationNumber Concentration | 500 | 108 | 1010 | /cm3 | 31 | #/cm3 | TARGET | 32 | TOB09 | PD | VAPE-Z27 | 9231 | CTMDDIAM | Count | median diameterMedian Diameter | 200 | 150 | 250 | nm | TARGET | 3332 | TOB09 | PD | VAPE-Z27 | 9532 | PM | PM PM2.5 | Particulate Matter 2.5 | ug/m3 | TARGET |
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*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio
Finally, the PT domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD. 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 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows. 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).
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Rows 1-32: | Show the tobacco design parameter specification test and the result in ORRES (needs populated).
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Row 28: | Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test. | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTTSTCND | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | |
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PTTPTPTTPTNUM | 1 | TOB09 | PT | VAPE-Z27 | |
| DRWRST | Draw | Resistance Resistance |
| DESIGN PARAMETER | SPECIFICATION TESTING |
| 91 | mm H2O | 91 | 91 | mm H2O | 1 | Week 01 | 2 | TOB09 | PT | VAPE-Z27 | 2 |
| PUFCNT | Puff | count (for full tank/cartridge) SPECIFICATION NUMBER COUNTNUMBER COUNT | 1 | Week 0 |
| 1 | 3 | TOB09 | PT | VAPE-Z27 | 3 |
| CRTVOL | Cartridge | volume SPECIFICATION mL | 1 | Week 0 | 1 | 4 | TOB09 | PT | VAPE-Z27 | 4 |
| HTELNUM | Number of | heating elementsHeating Elements |
| DESIGN PARAMETER | SPECIFICATION NUMBER COUNTNUMBER COUNTWeek 0 |
| 1 | 5 | TOB09 | PT | VAPE-Z27 | 5 |
| HTELGTH | Heating | element lengthElement Length |
| DESIGN PARAMETER | SPECIFICATION mm | 1 | Week 0HTELRST element resistanceElement Diameter |
| DESIGN PARAMETER | SPECIFICATION ohmohm | 1 | Week 0HTELRNG element rangeElement Resistance |
| DESIGN PARAMETER | SPECIFICATION CC1Week 0.77 | ohm | 1 | 8 | TOB09 | PT | VAPE-Z27 | 8 | HTELCFG element configurationElement Range |
| DESIGN PARAMETER | SPECIFICATION 1 | Week 0BTVLTORG | Battery voltage operating range
| HTELCFG | Heating Element Configuration |
| DESIGN PARAMETER | SPECIFICATION VV | 1 | Week 0BTCRTORG current operating rangeVoltage Operating Range |
| DESIGN PARAMETER | SPECIFICATION mAh | mAh | 1 | Week 0BATCAPC capacityCurrent Operating Range |
| DESIGN PARAMETER | SPECIFICATION mAh1Week 0BATNOMV nominal voltage SPECIFICATION VV1Week 0BTCRTRT Current RatingNominal Voltage |
| DESIGN PARAMETER | SPECIFICATION mA | 1 | Week 0BTCHTPL Charging Temperature LimitsCurrent Rating |
| DESIGN PARAMETER | SPECIFICATION C1Week 0BTDCTMPL Discharge Charging Temperature Limits |
| DESIGN PARAMETER | SPECIFICATION 1Week 0BTENDCV end of discharge voltageDischarge Temperature Limits |
| DESIGN PARAMETER | SPECIFICATION V | 1 | Week 0BTMXCHC maximum charging currentEnd of Discharge Voltage |
| DESIGN PARAMETER | SPECIFICATION mA | 1 | Week 0BTMXDCC maximum discharging currentMaximum Charging Current |
| DESIGN PARAMETER | SPECIFICATION 1 | Week 0BTULCHV upper limits charging voltageMaximum Discharging Current |
| DESIGN PARAMETER | SPECIFICATION V1Week 0PDUVOR |
| BTULCHV | Battery Upper Limits Charging Voltage | Power Delivery Unit (PDU) voltage operating range SPECIFICATION 1 | Week 0PDUCOR current operating rangeVoltage Operating Range |
| DESIGN PARAMETER | SPECIFICATION mA | 1 | Week 0PDUWTOR wattage operating rangeCurrent Operating Range |
| DESIGN PARAMETER | SPECIFICATION W | 1 | Week 0 | 1 | 23 | TOB09 | PT | VAPE-Z27 | 23 |
| PDUTCTOF | PDU | temperature cut (if applicable) SPECIFICATION 1 | Week 0 | 1 | 24 | TOB09 | PT | VAPE-Z27 | 24 |
| AIRFLRT | Airflow | rate SPECIFICATION 1 | Week 0 | 1 | 25 | TOB09 | PT | VAPE-Z27 | 25 |
| PDUCRCOF | PDU | current cut (if applicable) SPECIFICATION 1 | Week 0 | 1 | 26 | TOB09 | PT | VAPE-Z27 | 26 |
| INHAERT | Inhaled | aerosol temperatureAerosol Temperature |
| DESIGN PARAMETER | SPECIFICATION 1 | Week 0VENTLTN
| VENTLTOT | Total Ventilation |
| DESIGN PARAMETER | SPECIFICATION 1Week 0% | 1 | 28 | TOB09 | PT | VAPE-Z27 | 28 |
| ELQDVISC | E-Liquid | viscosityViscosity | Test performed at 20 degrees Celsius | DESIGN PARAMETER | SPECIFICATION TESTING1 | TESTING |
| 496 | mPa/s | 496 | 496 | mPa/s | Week 0 | 1 | 29 | TOB09 | PT | VAPE-Z27 | 29 |
| ELQDVOL | E-liquid | volume SPECIFICATION Week 060.1 | mL | 1 | 30 | TOB09 | PT | VAPE-Z27 | 30 |
| PNUMCNC | Particle | number concentrationNumber Concentration |
| DESIGN PARAMETER | SPECIFICATION #cm31 | Week 0 | 1 | 31 | TOB09 | PT | VAPE-Z27 | 31 |
| CTMDDIAM | Count | median diameterMedian Diameter |
| DESIGN PARAMETER | SPECIFICATION 1Week 0PM | PM SPECIFICATION m31 | Week 0 |
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