ISSUE:
- I think we need to make STRFID domain specific . That is use PTSTRID. This allow different reference Id to be used across domains. I think here you can use CAS, but in ingredients this does not work. IS it ok to keep , this meta example for the REFID. WE need to confirm with Richard how to describe.
- Need to clean up TL. SHould , we allow the ability to create look ups for UNI, etc. or delete and jsut show test condition for now.
- Neew to agree that PT is product testing domain name, and not Tobacco Product Testing. Should we create a model class of Product testing- and then allow domains by product in the future. .
The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct 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. Tobacco product HPHC testing results are represented in the PT domain. This example illustrates HPHC testing and smoking regimens for a cigarette product. The example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See Section 3.1.4, Stability Studies, for more information and examples illustrating how to represent those data.
This example only shows test results for each constituent for one 1 replicate of 1 sample of one 1 product that was tested . The sampling plan (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sposnor. In reality, sponsors would applicant or by regulatory requirement. Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset . These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample. by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.
Note the use of the PTXFN (external file name) to indicate that the lab methodology was submitted as separate documentation.
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| Rows 1-1517: | the on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. in smoke produced by a smoking machine from the tobacco product identified in SPTOBID (CIG01a). Note of the use of SPDEVID as the device identifier for the smoking machine and the use of PTREFID to identify the smoking regimen (non-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke. | | Row 18: | Shows 1 analyte was tested with a different smoking regimen (PTREFID=INTENSE REGIMEN) using the same smoking machine. | | Row 19: | Shows 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null. | Row 16: | Shows the HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID | PTTESTCD | PTTEST |
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PTTSTDTL | | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU |
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PTTSTCND | PTMETHODPTLLOQ| PTSPEC | PTREPNUM | PTDTC |
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| 1 | TOB07 | PT | CIG01a | PUFFMASTER3K | 1 |
Sample 1 | ACETALD| NON-INTENSE REGIMEN | ACTALD | Acetaldehyde |
QUANTITY TESTINGSMOKED PRODUCT | 1639 | 522 | ug/cigarette | 522 | 522 | ug/cigarette |
ISO INTENSE METHOD | GC-MS | | TL001_V5.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 2 | TOB07 | PT | CIG01a | PUFFMASTER3K | 2 |
Sample 1 | ACROL| NON-INTENSE REGIMEN | ACROLEIN | Acrolein |
QUANTITY TESTING154 | 43 | ug/cigarette | 43 | 43 | ug/cigarette |
ISO INTENSE METHOD | GC-MS | | TL002_V3.6.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 3 | TOB07 | PT | CIG01a | PUFFMASTER3K | 3 |
Sample 1 | ACRLONI| NON-INTENSE REGIMEN | ACRYNTRL | Acrylonitrile |
| | ISO INTENSE METHOD | | HPHC TESTING | HPHC | 7 | ug/cigarette | 7 | 7 | ug/cigarette | TL006_V6.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 4 | TOB07 | PT | CIG01a | PUFFMASTER3K | 4 |
Sample 1 | AMNPHEN4| NON-INTENSE REGIMEN | ABP4 | 4-Aminobiphenyl |
QUANTITY TESTINGISO INTENSE METHOD | TOBACCO LAB 1 | | 1.2 | ng/cigarette | 1.2 | 1.2 | ng/cigarette | TL008_V3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 5 | TOB07 | PT | CIG01a | PUFFMASTER3K | 5 |
Sample 1| NON-INTENSE REGIMEN | AMNPHTH1 | 1-Aminonaphthalene |
| | ISO INTENSE METHOD | | HPHC TESTING | HPHC | 14 | ng/cigarette | 14 | 14 | ng/cigarette | TL003_V1.4.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 6 | TOB07 | PT | CIG01a | PUFFMASTER3K | 6 |
Sample 1 | NH4 | Ammonia | QUANTITY | HPHC TESTING | 29.2 | ug/cigarette | ISO INTENSE METHOD | IC | | NON-INTENSE REGIMEN | AMNPHTH2 | 2-Aminonaphthalene | HPHC TESTING | HPHC | 8 | ng/cigarette | 8 | 8 | ng/cigarette | TL003_V1.4.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 7 | TOB07 | PT | CIG01a | PUFFMASTER3K | 7 |
Sample 1 | BENZ | Benzene | | | ISO INTENSE METHOD | | NON-INTENSE REGIMEN | AMMONIA | Ammonia | HPHC TESTING | HPHC | 9 | ug/cigarette | 9 | 9 | ug/cigarette | TL020_V4.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 8 | TOB07 | PT | CIG01a | PUFFMASTER3K | 8 |
Sample 1 | BENZAP | Benzo[a]pyrene | QUANTITY | HPHC TESTING | | NON-INTENSE REGIMEN | BENZENE | Benzene | HPHC TESTING | HPHC | 33 |
30.5ISO INTENSE METHOD | TOBACCO LAB 1 | | 33 | 33 | ug/cigarette | TL017_V1.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 9 | TOB07 | PT | CIG01a | PUFFMASTER3K | 9 |
Sample 1 | CO | Carbon monoxide | | | 28.2 | ug/cigarette | ISO INTENSE METHOD | TOBACCO LAB 1 | | NON-INTENSE REGIMEN | BZAPYR | Benzo[a]pyrene | HPHC TESTING | HPHC | 6.8 | ng/cigarette | 6.8 | 6.8 | ng/cigarette | TL017_V1.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 10 | TOB07 | PT | CIG01a | PUFFMASTER3K | 10 |
Sample 1 | CROTALD | Crotonaldehyde | QUANTITY | HPHC TESTING | 0.01 | ISO INTENSE METHOD | TOBACCO LAB 1 | 1 | | NON-INTENSE REGIMEN | CMONOX | Carbon Monoxide | HPHC TESTING | HPHC | 10.1 | mg/cigarette | 10.1 | 10.1 | mg/cigarette | TL019_V3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 11 | TOB07 | PT | CIG01a | PUFFMASTER3K | 11 |
Sample 1 | FORMALD | Formaldehyde | | | | NON-INTENSE REGIMEN | CROTNALD | Crotonaldehyde | HPHC TESTING | HPHC | 11 | ug/cigarette | 11 | 11 |
83.2ISO INTENSE METHOD | | TL001_V5.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 12 | TOB07 | PT | CIG01a | PUFFMASTER3K | 12 |
Sample 1 | ISOPRN | Isoprene | QUANTITY | HPHC TESTING | ISO INTENSE METHOD | | NON-INTENSE REGIMEN | FORMALD | Formaldehyde | HPHC TESTING | HPHC | 27 | ug/cigarette | 27 | 27 | ug/cigarette | TL001_V5.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 1 | 1 | 2022-09-30 | | 13 | TOB07 | PT | CIG01a | PUFFMASTER3K | 13 |
Sample 1 | NIC | Nicotine | | | 1.71 | ug/cigarette | ISO INTENSE METHOD | TOBACCO LAB 1 | | NON-INTENSE REGIMEN | ISOPRENE | Isoprene | HPHC TESTING | HPHC | 320 | ug/cigarette | 320 | 320 | ug/cigarette | TL041_V1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 14 | TOB07 | PT | CIG01a | PUFFMASTER3K | 14 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | HPHC TESTING | HPHC | 0.721 | mg/cigarette | 0.721 | 0.721 | mg/cigarette | TL007_V2.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 |
1414 | | PUFFMASTER3K | 15 | NON-INTENSE REGIMEN |
Sample 1derived | Derived Nitrosamine Ketone |
QUANTITY | HPHC TESTING | ISO INTENSE METHOD | | HPHC TESTING | HPHC | 71 | ng/cigarette | 71 | 71 | ng/cigarette | TL026_V12.2.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 11515 | | PUFFMASTER3K | 16 | NON-INTENSE REGIMEN |
Sample 1nitrosonornicotine | | 284| Nitrosonornicotine | HPHC TESTING | HPHC | 85 | ng/cigarette | 85 | 85 | ng/cigarette | TL026_V12.2.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 17 | TOB07 | PT | CIG01a | PUFFMASTER3K | 17 | NON-INTENSE REGIMEN | TOLUENE | Toluene | HPHC TESTING | HPHC | 53 | ug/cigarette | 53 | 53 | ug/cigarette |
ISO INTENSE METHOD | | TL011_V3.3.pdf | TPT LABCO | SMOKE |
TOBACCO LAB 116 | Sample 1 | ACETALD | | | | CANADIAN INTENSE METHOD | | PUFFMASTER3K | 18 | INTENSE REGIMEN | ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 1552 | ug/cigarette | 1552 | 1552 | ug/cigarette | TL009_V4.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 19 | TOB07 | PT | CIG01a |
| 19 |
| AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 | ug/g | 956 | 956 | ug/cigarette | TL016_V1.2.pdf | TPT LABCO | TOBACCO FILLER |
TOBACCO LAB 1 |
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This is the example meta data that the sponosr would include to describe the published references used to report STRFID.
Example PT Variable Metadata| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-11 |
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| Variable | Label | Type | Codelist |
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| STRFID | Substance Reference ID | text | CASREG |
Example External Dictionaries
...
Codelist
...
External Dictionary Name
...
Dictionary Version
...
Reference
The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the applicant-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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| 1 | TOB07 | DI | PUFFMASTER3K | 1 | DEVTYPE | Device Type | Smoking Machine |
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| 2 | TOB07 | DI | PUFFMASTER3K | 2 | MANUF | Manufacturer | Acme |
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| 3 | TOB07 | DI | PUFFMASTER3K | 3 | TRADENAM | Trade Name | PuffMaster 3000 |
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Details of the smoking regimen performed by the smoking machine are represented as device in-use properties (such as settings) of the smoking machine. They are linked to the HPHC testing results in PT by matching values of PTREFID/DUREFID.
...
https://commonchemistry.cas.org/?_ga=2.83414614.1907131087.1666302103-2054498898.1664568918
The Trial Lookup table can be used to provide additional details on any test conditions or methods used to perform the testing.
Additionally, TL can be used to provide different chemical reference information that may be used associated with the the substance ingredient. These different chemical substance reference numbers/codes are available in many published dictionaries, and may not be needed. This was used by the sponsors convenience only.
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| Rows 1-9: | Show the parameters of the non-intense smoking regimen. | | Rows 8-9: | Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this smoking regimen pauses for 60 seconds every 10 puffs. | | Rows 10-18: | Show the parameters of the intense smoking regimen. | | Rows 17-18: | Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this smoking regimen pauses for 30 seconds every 10 puffs. |
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| Dataset2 |
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| RDOMAIN | TLVAR1 | TLVRVAL1 | TLSEQ | TLPARMCD | TLPARM | TLVAL | TLVALU | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
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| 1 | TOB07 |
TLPTPTSTCONDISO METHOD1ISOSTNUM | ISO Standard Number | ISO 3308| Puff Profile | SQUARE |
| SQUARE |
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| | 2 | TOB07 |
TLPTPTSTCONDISO INTENSE METHOD | 2 | PUFFVOL | Puff Volume | 34 | mg| NON-INTENSE REGIMEN |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 |
TLPTPTSTCONDISO INTENSE METHOD| NON-INTENSE REGIMEN |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 |
TEMP | Temperature | | 4 | TOB07 | TL | PT | PTMETHOD | ISO INTENSE METHOD | 4 | PUFFVOL | Puff Volume | 35 | mg | 5 | TOB07 | TL | PT | PTMETHOD | ISCEV STANDARD | 1 | PUFFDUR | Puff Duration | PT10M | 6 | TOB07 | TL | PT | PTMETHOD | ISCEV STANDARD | 2 | SMOKMAC | Smoking Machine | BigPUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | NON-INTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | NON-INTENSE REGIMEN |
| | Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | NON-INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | NON-INTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | NON-INTENSE REGIMEN | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | NON-INTENSE REGIMEN | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF | | 10 | TOB07 | DU | PUFFMASTER3K | 1 | INTENSE REGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 11 | TOB07 | DU | PUFFMASTER3K | 2 | INTENSE REGIMEN |
| PUFFDUR | Puff Duration | 2.25 | sec | 2.25 | 2.25 | sec | | 12 | TOB07 | DU | PUFFMASTER3K | 3 | INTENSE REGIMEN |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 13 | TOB07 | DU | PUFFMASTER3K | 4 | INTENSE REGIMEN |
| PUFFBLCK | Puff Block | 30 | % | 30 | 30 | % | | 14 | TOB07 | DU | PUFFMASTER3K | 5 | INTENSE REGIMEN |
| PUFFNUM | Number of Puffs | 100 | PUFF | 100 | 100 | PUFF | | 15 | TOB07 | DU | PUFFMASTER3K | 6 | INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 20 | mL | 20 | 20 | mL | | 16 | TOB07 | DU | PUFFMASTER3K | 7 | INTENSE REGIMEN |
| PUFFRNG | Puff Range | 50-150 |
| 50-150 |
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| | 17 | TOB07 | DU | PUFFMASTER3K | 8 | INTENSE REGIMEN | 2 | PUFFPAUS | Puff Pause | 30 | s | 30 | 30 | s | | 18 | TOB07 | DU | PUFFMASTER3K | 9 | INTENSE REGIMEN | 2 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
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