Tobacco product HPHC testing study results are represented in PT. These are just the data that show the testing results under specific storage conditions and smoking regimens. The details of the regimen and storage conditions are shown in separate datasets that follow this example.
- The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
- The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
- The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
- We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.
- PTCAT represents the type of testing such as HPHC Testing or Design Parameter Testing
- PTSCAT represents HPHC vs other constituents
This example assumes one-off testing, not serial testing in stability studies. See the Stability studies examples for more information on handling those data.
The following references were used as guidance for the example below: https://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example. 2 https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345
This testing is conducted on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product. https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345
This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset.
...
...
.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-17: | Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition is represented in STOCONID. | | Rows 5-6: | Show the same analyte from two different sources | | Rows 14-16: | Show three analytes that were tested in smoke produced by a smoking machine. SPDEVID indicates the smoking machine identified in the DI dataset example below. The smoking regimen is shown in PTREFID. The parameters of the smoking regimen are represented in the DU domain (example below) and are matched by using the same value of DUREFID). Note that PTSPEC (Matrix Type) is "SMOKE" for these 3 records (vs "TOBACCO") for all other records in this dataset. | | Rows 18-19: | Show the HPHC testing performed on one sample for two ingredients using the CANDIAN INTENSE test conditions. Row 18 Specimen is Smoke and Row 19 Specimen is Filler. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID |
|---|
STOCONID | PTSEQ | PTREFID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM | PTDTC |
|---|
| 1 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 1 |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 522 | µg/cigarette | 522 | 522 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 2 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 2 |
| 107-02-8 | ACROL | Acrolein | HPHC TESTING | HPHC | 43 | µg/cigarette | 43 | 43 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 3 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 3 |
| 107-13-1 | ACRLONI | Acrylonitrile | HPHC TESTING | HPHC | 7 | µg/cigarette | 7 | 7 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 4 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 4 |
| 92-67-1 | AMNPHEN4 | 4-Aminobiphenyl | HPHC TESTING | HPHC | 1.2 | ng/cigarette | 1.2 | 1.2 | ng/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 5 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 5 |
| 134-32-7 | AMNPHTH1 | 1-Aminonaphthalene | HPHC TESTING | HPHC | 14 | ng/cigarette | 14 | 14 | ng/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 6 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 6 |
| 134-32-7 | AMNPHTH2 | 2-Aminonaphthalene | HPHC TESTING | HPHC | 8 | ng/cigarette | 8 | 8 | ng/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 7 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 7 |
| 7664-41-7 | NH4 | Ammonia | HPHC TESTING | HPHC | 9 | µg/cigarette | 9 | 9 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 8 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition | BENZ| BENZN | Benzene | HPHC TESTING | HPHC | 33 | µg/cigarette | 33 | 33 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 9 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) ConditionBENZAP| BENZOAP | Benzo[a]pyrene | HPHC TESTING | HPHC | 6.8 | ng/cigarette | 6.8 | 6.8 | ng/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 10 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 10 |
| 630-08-0 | CO | Carbon monoxide | HPHC TESTING | HPHC | 10.1 | mg/cigarette | 10.1 | 10.1 | mg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 11 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 11 |
| 4170-30-3 | CROTALD | Crotonaldehyde | HPHC TESTING | HPHC | 11 | µg/cigarette | 11 | 11 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 12 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 12 |
| 50-00-0 | FORMALD | Formaldehyde | HPHC TESTING | HPHC | 27 | µg/cigarette | 27 | 27 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 13 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 13 |
| 78-79-5 | ISOPRN | Isoprene | HPHC TESTING | HPHC | 320 | µg/cigarette | 320 | 320 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 14 | TOB07 | PT | CIG01a | PUFFMASTER3K |
E-Liquid Standard (Long Term) Condition | 14 | Medium Intensity Regimen | 1954-11-05 | NIC | Nicotine | HPHC TESTING | HPHC | 0.721 | mg/cigarette | 0.721 | 0.721 | mg/cigarette | SMOKE | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 15 | TOB07 | PT | CIG01a | PUFFMASTER3K |
E-Liquid Standard (Long Term) Condition | | 15 | Medium Intensity Regimen | 64091-91-4 | NNK |
4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone| Nicotine-Derived Nitrosamine Ketone | HPHC TESTING | HPHC | 71 | ng/cigarette | 71 | 71 | ng/cigarette | SMOKE | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 16 | TOB07 | PT | CIG01a | PUFFMASTER3K |
E-Liquid Standard (Long Term) Condition | | 16 | Medium Intensity Regimen | 16543-55-8 | NNN | N-nitrosonornicotine | HPHC TESTING | HPHC | 85 | ng/cigarette | 85 | 85 | ng/cigarette | SMOKE | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 17 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 17 |
| 108-88-3 | TOLUENE | Toluene | HPHC TESTING | HPHC | 53 | µg/cigarette | 53 | 53 | µg/cigarette |
SMOKE| TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 18 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 18 |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 1552 | µg/cigarette | 1552 | 1552 | µg/cigarette |
SMOKE| TOBACCO | CANADIAN INTENSE METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 19 | TOB07 | PT | CIG01a |
E-Liquid Standard (Long Term) Condition |
| 19 |
| 7664-41-7 | AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 | µg/g | 956 | 956 | µg/cigarette | FILLER | CANADIAN INTENSE METHOD | 1 | Week 0 | 1 | 2022-09-30 |
|
|
Next ,we use DU (device-in use properties/settings) for smoking regimen. Note that the separate DI (device identifiers) dataset is needed to show identifying parameters of the "PUFFMASTER3K" smoking machine. We cannot have DU without also including DI).The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
|---|
| 1 | TOB07 | DI | PUFFMASTER3K | 1 | DEVTYPE | Device Type | Smoking Machine |
|---|
| 2 | TOB07 | DI | PUFFMASTER3K | 2 | MANUF | Manufacturer | Acme |
|---|
| 3 | TOB07 | DI | PUFFMASTER3K | 3 | TRADENAM | Trade Name | PuffMaster 3000 |
|---|
|
|
Details of the smoking regimen performed by the smoking machine are represented as device in-use properties, linked to the stability data HPHC testing results in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input)..
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| STUDYID | DOMAIN | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
|---|
| 1 | TOB07 | DU | PUFFMASTER3K | 1 | Medium Intensity Regimen |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
|
| | 2 | TOB07 | DU | PUFFMASTER3K | 2 | Medium Intensity Regimen |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 | Medium Intensity Regimen |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | Medium Intensity Regimen |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | Medium Intensity Regimen |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | Medium Intensity Regimen |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | Medium Intensity Regimen |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
|
| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | Medium Intensity Regimen | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | Medium Intensity Regimen | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
|
|
Finally, we assume we still need to parse out storage conditions of "E-Liquid Standard (Long Term) Condition". Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset.
- The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
- These values were made up, but we assume they'd look something like this.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
|---|
| 1 | TOB07 | ES | E-Liquid Standard (Long Term) Condition | 1 | HUMID | Humidity | 38 | % | 2 | TOB07 | ES | E-Liquid Standard (Long Term) Condition | 2 | TEMP | Temperature | 25 | C |
|