The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the Tobacco Product Testing (PT) domain, with PTCAT = STABILITY TESTING.
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The first pt.xpt dataset shows 22 consituents and parameters each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study. Some constituent names (values of PTTESTCD/PTTEST) appear twice because they are tested separately in both e-liquid and aerosol (as indicated by PTSPEC). Note that the constituent names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM. |
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- The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (shown in SPDEVID) was used to perform the vaping regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.2, HPHCs, Other Constituents, and Smoking / Vaping Regimens.
- PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent when such methodology is too complex for the single PTMETHOD variable.
- STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the Environmental Storage Conditions (ES) dataset example that follows the 2 PT dataset examples.
- In this example, the applicant chose to subcategorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
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| Rows 1, 3, 5, 7, 9, 10, 15, 17-19, 22, 24, 25, 27-31: | Show the results of testing for constituents in samples of e-liquid product (PTSPEC=E-LIQUID). | | Rows 2, 4, 6, 8, 11-14, 16, 20, 21, 23, 26: | Show the results of testing for constituents/parameters in aerosol produced from the e-liquid product. The smoking machine is shown in SPDEVID and the regimen is shown in PTREFID. |
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THIS EXAMPLE IS UNDER RE-CONSTRUCTION FOLLOWING THE TEAM CALL ON 17 JAN. See also example in the "sandbox' here, which demonstrates the current approach reviewed on that call. |
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NOTE TO TEAM REVIEWERS: The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study.
The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example study. For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows: First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated. Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like. Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group. |
The example shown below is not an all inclusive comprehensive example. It is meant to be illustrative of the concepts.
Shelf life study has a protocol and provides the results of shelf life studies of Vapes products over time with different conditions and analytes. Generally there are many conditions with at least two with varying temperature, humidity, etc. The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for Vapes products for one testing condition at one timepoint and one replicate.
Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.
PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.
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| Rows 1-20: | Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition. | | Rows 2, 12, 13: | Show the Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable. | Rows 17, 18: | Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is E-Liquid Standard (Long Term) Condition. |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONDID | PTSEQ | PTREFID |
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PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT |
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PTTSTCND | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU |
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PTMATRIXPTSPCCNDPTMETHOD| PTSPEC | PTLLOQ | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | 111 |
| Condition 1 |
VAP77777.54-11-5 | NIC | | NICOTINE | Nicotine | STABILITY |
STUDYE-Liquid Standard (Long Term) Condition| TESTING |
| 35.94 | mg/g |
| 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
1Week 2 | TOB07 | PT | 111 | 2 | VAP77777.1 | 54-11-5 | NIC | Nicotine | STABILITY STUDY | E-Liquid Standard (Long Term) Condition | AEROSOL | 1 | 33VAP77777.494-97-3 | XXXXX | Nornicotine STABILITY STUDY | Nicotine Degradant | E-Liquid Standard (Long Term) Condition | E-LIQUID | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | STABILITY TESTING |
| | mg/PUFF |
| 0.1039 | 0.1039 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
14VAP77777.4 | 494-52-0 | XXXXX | Anabasine STUDY| TESTING | Nicotine Degradant |
E-Liquid Standard (Long Term) Condition| 25.76 | ug/g |
| 25.76 | 25.76 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
55VAP77777.56-81-5 | XXXXX | Glycerin | STABILITY STUDY | Primary Ingredient | E-Liquid Standard (Long Term) Condition | E-LIQUID | | NON-INTENSE REGIMEN | NORNCTN | | STABILITY TESTING | Nicotine Degradant | 0.0392 | ug/PUFF |
| 0.0392 | 0.0392 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
16VAP77777.6 | 57-55-6 | XXXXX | Propylene Glycol | STABILITY STUDY | Primary Ingredient | E-Liquid Standard (Long Term) Condition| 5 |
| GLYCRL | Glycerol | STABILITY TESTING | Primary Ingredient | 615.68 | mg/g |
| 615.68 | 615.68 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
1Week 7 | | 02-01-2023 | Week 0 | 1 | | 6 | TOB07 | PT | 111 |
7VAP77777.65-85-0 | XXXXX | Benzoic Acid | STABILITY STUDY | Acid | E-Liquid Standard (Long Term) Condition | E-LIQUID | 1 | Week 0 | 1 | 8 | TOB07 | PT | 111 | 8 | VAP77777.1 | 89-78-1 confirm this one, there are two - the other is 1490-04-6 | 6 | NON-INTENSE REGIMEN | GLYCRL | Glycerol | STABILITY TESTING | Primary Ingredient | 1.81 | mg/PUFF | 0.00144 | 1.81 | 1.81 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 7 | TOB07 | PT | 111 |
| Condition 1 | 7 |
| PRPYLGLY | Propylene Glycol | STABILITY TESTING | Primary Ingredient | 218.21 | mg/g |
| 218.21 | 218.21 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 |
XXXXX | Menthol | STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition | E-LIQUID | 1 | Week 0 | 1 | 9 | TOB07 | PT | 111 | 9 | VAP77777.1 | XXXXX | Vanillin | STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition | E-LIQUID | 11010VAP77777.64091-91-4 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition | E-LIQUID | 1 | | NON-INTENSE REGIMEN | PRPYLGLY | Propylene Glycol | STABILITY TESTING | Primary Ingredient | 0.8565 | mg/PUFF | 0.00024 | 0.8565 | 0.8565 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
11VAP77777.11 | 80508-23-2 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition| 9 |
| BNZOICAC | Benzoic Acid | STABILITY TESTING | Acid | 42.2 | ug/PUFF |
| 42.2 | 42.2 | ug/PUFF | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
1212 | VAP77777.1 | 64091-91-4 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition | AEROSOL | 1 | Week 0 | 1 |
| Condition 1 | 10 |
| MENTHOL | Menthol | STABILITY TESTING | Flavorant | 37.53 | mg/g |
| 37.53 | 37.53 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 11 |
13 | TOB07 | PT | 111 | 13 | VAP77777.1 | 80508-23-2 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition | AEROSOL | 1 | Week 0 | 1 | 1414VAP77777.XXXXXMetals - Nickel | STABILITY STUDY | Extractables / Leachables | E-Liquid Standard (Long Term) Condition | E-LIQUID | | NON-INTENSE REGIMEN | MENTHOL | Menthol | STABILITY TESTING | Flavorant | 0.5881 | mg/PUFF | 0.00024 | 0.5881 | 0.5881 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
11515VAP77777.PH | pH | STABILITY STUDY | E-Liquid Standard (Long Term) Condition | E-LIQUID | | 12 | NON-INTENSE REGIMEN | GLYCDOL | Glycidol | STABILITY TESTING | Stabilizer | NOT DETECTED |
| 0.00011 | NOT DETECTED |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
11616VAP77777.XXXXX | Endotoxin | STABILITY STUDY | Toxins | E-Liquid Standard (Long Term) Condition | E-LIQUID | 1 | Week 0 | 1 | | 13 | NON-INTENSE REGIMEN | FRMLDHD | Formaldehyde | STABILITY TESTING |
| 0.0728 | ug/PUFF | 0.00549 | 0.0728 | 0.0728 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
17 | TOB07 | PT | 111 | 17 | VAP77777.1 | XXXXX | TAMC | STABILITY STUDY | Microbiological | E-Liquid Standard (Long Term) Condition | E-LIQUID | 11818VAP77777.XXXXX | TYMC | STABILITY STUDY | Microbiological | E-Liquid Standard (Long Term) Condition | E-LIQUID | 1 | Week 0 | 1 | | 14 | NON-INTENSE REGIMEN | ACROLN | Acrolien | STABILITY TESTING |
| DETECTED, BELOW LLOQ |
| 0.00928 | DETECTED, BELOW LLOQ |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
19 | TOB07 | PT | 111 | 19 | VAP77777.1 | 75-07-0 | XXXXX | Acetaldehyde | STABILITY STUDY | Aldehyde | E-Liquid Standard (Long Term) Condition | E-LIQUID | 120VAP77777.20 | XXXXX | Acetyl propionyl | STABILITY STUDY | Diketone | E-Liquid Standard (Long Term) Condition| 15 |
| LACTICAC | Lactic Acid | STABILITY TESTING |
| 40.44 | ug/g |
| 40.44 | 40.44 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
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A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.
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| | 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 16 | NON-INTENSE REGIMEN | LACTICAC | Lactic Acid | STABILITY TESTING |
| 29.71 | ug/PUFF | 0.284 | 29.71 | 29.71 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 17 | TOB07 | PT | 111 |
| Condition 1 | 17 |
| VANLLN | Vanillin | STABILITY TESTING | Flavorant | 1.12 | ug/g |
| 1.12 | 1.12 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 18 | TOB07 | PT | 111 |
| Condition 1 | 18 |
| NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY TESTING | HPHC | 0.0711 | ug/g |
| 0.0711 | 0.0711 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 19 | TOB07 | PT | 111 |
| Condition 1 | 19 |
| NNN | N-Nitrosonornicotine | STABILITY TESTING | HPHC | 0.0852 | ug/g |
| 0.0852 | 0.0852 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 20 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 20 | NON-INTENSE REGIMEN | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY TESTING | HPHC | 0.0577 | ug/PUFF |
| 0.0577 | 0.0577 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 21 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 21 | NON-INTENSE REGIMEN | NNN | N-Nitrosonornicotine | STABILITY TESTING | HPHC | 0.0742 | ug/PUFF |
| 0.0742 | 0.0742 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 22 | TOB07 | PT | 111 |
| Condition 1 | 22 |
| NICKEL | Nickel | STABILITY TESTING | Extractables / Leachables | 0.0897 | ug/g |
| 0.0897 | 0.0897 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 23 | NON-INTENSE REGIMEN | MASS | Mass | STABILITY TESTING |
| 3.87 | mg/PUFF | 0.0071 | 3.87 | 3.87 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 24 | TOB07 | PT | 111 |
| Condition 1 | 24 |
| CHROMIUM | Chromium | STABILITY TESTING |
| NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 25 | TOB07 | PT | 111 |
| Condition 1 | 25 |
| PH | | STABILITY TESTING |
| 7.15 |
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| 7.15 | 7.15 |
| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 26 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 26 | NON-INTENSE REGIMEN | PH | pH | STABILITY TESTING |
| 7.24 |
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| 7.24 | 7.24 |
| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 27 | TOB07 | PT | 111 |
| Condition 1 | 27 |
| ENDTXN | Endotoxin | STABILITY TESTING | Toxins | NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 28 | TOB07 | PT | 111 |
| Condition 1 | 28 |
| AEBCT | Aerobic Colony Count | STABILITY TESTING | Microbiological | <1 | CFU/mL |
| <1 |
| CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 29 | TOB07 | PT | 111 |
| Condition 1 | 29 |
| YSTMLDCT | Yeast and/or Mold Colony Count | STABILITY TESTING | Microbiological | 1 | CFU/mL |
| 1 | 1 | CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 30 | TOB07 | PT | 111 |
| Condition 1 | 30 |
| ACTALD | Acetaldehyde | STABILITY TESTING | Aldehyde | 7.8 | ug/mL |
| 7.8 | 7.8 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 31 | TOB07 | PT | 111 |
| Condition 1 | 31 |
| ACTPROPN | Acetyl Propionyl | STABILITY TESTING | Diketone | 32.4 | ug/mL |
| 32.4 | 32.4 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
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The second PT dataset shows testing for just 1 constituent (nicotine), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 3 sets of storage conditions (STOCONID), in samples of e-liquid and aerosol (PTSPEC) in order to illustrate how those variables are used to represent their associated concepts in a stability study. |
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- As in the first PT dataset, the details of the smoking machine and vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens.
- Details of the 3 conditions are represented in the ES dataset example that follows.
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| Dataset2 |
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| Row | | DOMAIN | SPTOBID | SPDEVID | STOCONID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTNAM | PTXFN | PTSPEC | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | 111 |
| Condition 1 | 211 |
| NICOTINE | | 35.94 | mg/g | 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 02-01-2023 | Week 0 | 1 | | 2 | TOB07 | PT | 111 |
| Condition 1 | 212 | | | Nicotine | 35.46 | mg/g | 35.46 | 35.46 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 02-01-2023 | Week 0 | 1 | | 3 | TOB07 | PT | 111 |
| Condition 1 | 213 |
| NICOTINE | Nicotine | 35.97 | mg/g | 35.97 | 35.97 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 02-01-2023 | Week 0 | 1 | | 4 | TOB07 | PT | 111 |
| Condition 1 | 214 |
| NICOTINE | Nicotine | 35.55 | mg/g | 35.55 | 35.55 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 03-29-2023 | Week 8 | 2 | | 5 | TOB07 | PT | 111 |
| Condition 1 | 215 |
| NICOTINE | Nicotine | 35.88 | mg/g | 35.88 | 35.88 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 03-29-2023 | Week 8 | 2 | | 6 | TOB07 | PT | 111 |
| Condition 1 | 216 |
| NICOTINE | Nicotine | 35.67 | mg/g | 35.67 | 35.67 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 03-29-2023 | Week 8 | 2 | | 7 | TOB07 | PT | 111 |
| Condition 1 | 217 |
| NICOTINE | Nicotine | 36.11 | mg/g | 36.11 | 36.11 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 07-19-2023 | Week 24 | 3 | | 8 | TOB07 | PT | 111 |
| Condition 1 | 218 |
| NICOTINE | Nicotine | 35.72 | mg/g | 35.72 | 35.72 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 07-19-2023 | Week 24 | 3 | | 9 | TOB07 | PT | 111 |
| Condition 1 | 219 |
| NICOTINE | Nicotine | 35.54 | mg/g | 35.54 | 35.54 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 07-19-2023 | Week 24 | 3 | | 10 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 220 | NON-INTENSE REGIMEN | NICOTINE | | 0.1039 | mg/PUFF | 0.1039 | 0.1039 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 02-01-2023 | Week 0 | 1 | | 11 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 221 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1142 | mg/PUFF | 0.1142 | 0.1142 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 02-01-2023 | Week 0 | 1 | | 12 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 222 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1282 | mg/PUFF | 0.1282 | 0.1282 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 02-01-2023 | Week 0 | 1 | | 13 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 223 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1242 | mg/PUFF | 0.1242 | 0.1242 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 03-29-2023 | Week 8 | 2 | | 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 224 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1084 | mg/PUFF | 0.1084 | 0.1084 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 03-29-2023 | Week 8 | 2 | | 15 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 225 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1174 | mg/PUFF | 0.1174 | 0.1174 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 03-29-2023 | Week 8 | 2 | | 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 226 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1374 | mg/PUFF | 0.1374 | 0.1374 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 07-19-2023 | Week 24 | 3 | | 17 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 227 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1364 | mg/PUFF | 0.1364 | 0.1364 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 07-19-2023 | Week 24 | 3 | | 18 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 228 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1264 | mg/PUFF | 0.1264 | 0.1264 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 07-19-2023 | Week 24 | 3 | | 19 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 229 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1256 | mg/PUFF | 0.1256 | 0.1256 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 02-01-2023 | Week 0 | 1 | | 20 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 230 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1236 | mg/PUFF | 0.1236 | 0.1236 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 02-01-2023 | Week 0 | 1 | | 21 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 231 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1126 | mg/PUFF | 0.1126 | 0.1126 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 02-01-2023 | Week 0 | 1 | | 22 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 232 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1334 | mg/PUFF | 0.1334 | 0.1334 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 03-29-2023 | Week 8 | 2 | | 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 233 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1134 | mg/PUFF | 0.1134 | 0.1134 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 03-29-2023 | Week 8 | 2 | | 24 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 234 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1125 | mg/PUFF | 0.1125 | 0.1125 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 03-29-2023 | Week 8 | 2 | | 25 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 235 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1156 | mg/PUFF | 0.1156 | 0.1156 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 07-19-2023 | Week 24 | 3 | | 26 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 236 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1145 | mg/PUFF | 0.1145 | 0.1145 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 07-19-2023 | Week 24 | 3 | | 27 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 237 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1157 | mg/PUFF | 0.1157 | 0.1157 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 07-19-2023 | Week 24 | 3 |
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Details of the storage conditions are represented in the ES dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The ES dataset shows all 3 sets of storage conditions used across both of the PT dataset examples.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
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| 1 | TOB07 | ES | Condition 1 | 1 | HUMID | Humidity | 37 | % | | 2 | TOB07 | ES | Condition 1 | 2 | TEMP | Temperature | 24 | C | | 3 | TOB07 | ES | Condition 2 | 1 | HUMID | Humidity | 60 | % | | 4 | TOB07 | ES | Condition 2 | 2 | TEMP | Temperature | 27 | C | | 5 | TOB07 | ES | Condition 3 | 1 | HUMID | Humidity | 95 | % | | 6 | TOB07 | ES | Condition 3 | 2 | TEMP | Temperature | 31 | C |
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The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.
The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above.
(We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU)
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| Dataset2 |
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| Row | STUDYID | DOMAIN | RDOMAIN | TCVAR1 | TCVRVAL1 | TCSEQ | TCGRPID | TCPARMCD | TCPARM | TCVAL | TCVALU |
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1 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 1 | PUFFPROF | Puff Profile | SQUARE | 2 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 2 | PUFFDUR | Puff Duration | 1.25 | sec | 3 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 3 | PUFFINT | Puff Interval | 3 | PUFF/min | 4 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 4 | PUFFBLCK | Puff Block | 25 | % | 5 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 5 | NUMPUFF | Total Number of Puffs | 200 | PUFF | 6 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 6 | PUFFVOL | Puff Volume | 10 | mL | 7 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 7 | PUFFRNG | Puff Range | 100-200 | | 8 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 8 | 1 | PUFFPAUS | Puff Pause | 60 | s | | 9 | TOB07 | TC | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 9 | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF |
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