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 STUDYTESTING.
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The first pt.xpt dataset shows 12 constituents 22 consituents and parameters each as a single replicate (PTREPNUM=1), at one 1 time point and one (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. Note that the Some constituent names shown do not represent an exhaustive list of the controlled terminology that will be developed (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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| Rows 1-31: | Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in STOCONDID which is Condition 1. | | Rows 2, 4, 6, 8, 11, 12, 13, 14, 16, 20, 21, 23, 26: | Show the several analytes such as 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 28, 29: | Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTSCAT variable. | | Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONDID | PTSEQ | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTNAM | PTXFN | PTSPEC | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | 111 | Condition 1 | | NICOTINE | Nicotine | STABILITY STUDY | 35.94 | mg/g | 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | 2 | | Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONDID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTNAM | PTXFN | PTSPEC | PTLLOQ | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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| 1 |
2 | | NICOTINE | Nicotine | STABILITY |
STUDY01039PUFF0103901039PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
3| 2 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
3 | NORNCTN | | STABILITY STUDY | Nicotine Degradant | 25.76 | ug/g | 25.76 | 25.76 | | 2 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | STABILITY TESTING |
| | mg/PUFF |
| 0.1039 | 0.1039 | mg/PUFF |
ug/gTLEL01v15E-LIQUID| AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
44 STUDY| TESTING | Nicotine Degradant |
00392PUFF0039200392PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
5| 4 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
5 | GLYCRL | Glycerol | STABILITY STUDY | Primary Ingredient | 615.68 | mg/g | 615.68 | 615.68 | | 4 | NON-INTENSE REGIMEN | NORNCTN | | STABILITY TESTING | Nicotine Degradant | 0.0392 | ug/PUFF |
| 0.0392 | 0.0392 | ug/PUFF |
mg/gTLEL01v15E-LIQUID| AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
66 STUDY| TESTING | Primary Ingredient |
181PUFF0001441811.81 | PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
7| 6 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
7 | PRPYLGLY | Propylene Glycol | | 6 | NON-INTENSE REGIMEN | GLYCRL | Glycerol | STABILITY TESTING |
STABILITY STUDY21821g218.21 | 218.21gTLEL01v15E-LIQUID| AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
88| 7 |
| PRPYLGLY | Propylene Glycol | STABILITY |
STUDY| TESTING | Primary Ingredient |
08565PUFF000024085650.8565 | PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
9| 8 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
9 | BNZOICAC | Benzoic Acid | STABILITY STUDY | Acid | 42.2 | ug/PUFF | 42.2 | 42.2 | | 8 | NON-INTENSE REGIMEN | PRPYLGLY | Propylene Glycol | STABILITY TESTING | Primary Ingredient | 0.8565 | mg/PUFF | 0.00024 | 0.8565 | 0.8565 | mg |
ugTLEL01v15E-LIQUID| AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
1010MENTHOLMenthol STUDYFlavorant3753mgg37533753mgg| PUFF | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
1111| 10 |
| MENTHOL | Menthol | STABILITY |
STUDY05881PUFF000024058810.5881 | PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
12| 11 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
12 | GLYCDOL | Glycidol | STABILITY STUDY | Stabilizer | NOT DETECTED | 0.00011 | | 11 | NON-INTENSE REGIMEN | MENTHOL | Menthol | STABILITY TESTING | Flavorant | 0.5881 | mg/PUFF | 0.00024 | 0.5881 | 0.5881 | mg/PUFF |
NOT DETECTED | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 |
Week 13| 12 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
13 | FRMLDHD | Formaldehyde | STABILITY STUDY | 0.0728 | ug/PUFF | 0.00549 | 0.0728 | 0.0728 | ug/PUFF | | 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 | Week 0 | 1 |
14| 13 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
14 | ACROLN | Acrolien | STABILITY STUDY | DETECTED, BELOW LLOQ | 0.00928 | | 13 | NON-INTENSE REGIMEN | FRMLDHD | Formaldehyde | STABILITY TESTING |
| 0.0728 | ug/PUFF | 0.00549 | 0.0728 | 0.0728 | ug/PUFF |
DETECTED, BELOW LLOQ | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
15| 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
15 | LACTICAC | Lactic Acid | STABILITY STUDY | 40.44 | ug/g | 40.44 | 40.44 | | 14 | NON-INTENSE REGIMEN | ACROLN | Acrolien | STABILITY TESTING |
| DETECTED, BELOW LLOQ |
| 0.00928 | DETECTED, BELOW LLOQ |
ug/gTLEL01v15E-LIQUIDAEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
1616| 15 |
| LACTICAC | Lactic Acid | STABILITY |
STUDY2971PUFF028429.7129.71 | PUFFTLAE01v21AEROSOLE-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
17| 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
17 | VANLLN | Vanillin | STABILITY STUDY | Flavorant | 1.12 | ug/g | 1.12 | 1.12 | | 16 | NON-INTENSE REGIMEN | LACTICAC | Lactic Acid | STABILITY TESTING |
| 29.71 | ug/PUFF | 0.284 | 29.71 | 29.71 | ug/PUFF |
ug/gTLEL01v15E-LIQUIDAEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
1818NNK | Nicotine-Derived Nitrosamine Ketone STUDYHPHC007110071100711| 12 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
1919NNNNNitrosonornicotine| Derived Nitrosamine Ketone | STABILITY |
STUDY085208520852| 0711 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
2020NNKNicotineDerived Nitrosamine Ketone| Nitrosonornicotine | STABILITY |
STUDY0577PUFF05770577PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
21| 20 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
21 | NNN | N-Nitrosonornicotine | | 20 | NON-INTENSE REGIMEN | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY TESTING |
STABILITY STUDY074207420742| 0577 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
22| 21 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
22 | NICKEL | Nickel | STABILITY STUDY | | 21 | NON-INTENSE REGIMEN | NNN | N-Nitrosonornicotine | STABILITY TESTING | HPHC |
Extractables / Leachables0897g08970897gTLEL01v15E-LIQUID| AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
2323MASSMass STUDY3.87 | | TESTING | Extractables / Leachables | 0.0897 | ug/g |
mg/PUFF00713873.87 | mg/PUFFTLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
24| 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
24 | CHROMIUM | Chromium | STABILITY STUDY | NOT DETECTED | | 23 | NON-INTENSE REGIMEN | MASS | Mass | STABILITY TESTING |
| 3.87 | mg/PUFF | 0.0071 | 3.87 | 3.87 | mg/PUFF |
NOT DETECTEDTLEL01v15E-LIQUIDWeek 0 | 2525PHpH STUDY7.15 | 7.15 | 7.15 | | 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 |
2626 STUDY242424TLAE01v21AEROSOL| E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
27| 26 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
27 | ENDTXN | Endotoxin | STABILITY STUDY | Toxins | NOT DETECTED | | 26 | NON-INTENSE REGIMEN | PH | pH | STABILITY TESTING |
| 7.24 |
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| 7.24 | 7.24 |
NOT DETECTEDTLEL01v15E-LIQUID| AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
2828AEBPLCTAerobic Plate Count STUDYMicrobiological<1 | CFU/mL | <1 | CFU/mL | TPT LABCO | | NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01 |
TLEL01| _v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
2929TYMC | Total Yeast and/or Mold
| AEBCT | Aerobic Colony Count | STABILITY |
STUDY111 | | <1 |
| CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
3030ACTALD |
| YSTMLDCT | Yeast and/or Mold Colony Count |
Acetaldehyde STUDYAldehyde7.8ug7.8 | 7.8 | ug| /mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
3131ACTPROPNAcetyl Propionyl STUDYDiketone324324324| 8 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 31 | TOB07 | PT | 111 |
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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.
| 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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| Rows 1-9: | Show the PTTEST of Nicotine for Condition 1 which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test. |
| Rows 10-19: | Show the PTTEST of Nicotine for Condition 2 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. |
Rows 20-27: | Show the PTTEST of Nicotine for Condition 3 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. | | Dataset2 |
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| Row | | DOMAIN | SPTOBID | SPDEVID | STOCONID | PTSEQ | PTGRPIDPTREFID | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTNAM | PTXFN | PTSPEC | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | 111 |
| Condition 1 | 2111 |
| 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 | 2121 | | | 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 | 1 |
| 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 | 1 |
| NICOTINE | Nicotine | 35.55 | mg/g | 35.55 | 35.55 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | Week 24 | 03-29-2023 | Week 8 | 24 | | 5 | TOB07 | PT | 111 |
| Condition 1 | 215 | 1 |
| NICOTINE | Nicotine | 35.88 | mg/g | 35.88 | 35.88 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | Week 24 | 03-29-2023 | Week 8 | 24 | | 6 | TOB07 | PT | 111 |
| Condition 1 | 2161 |
| 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 248 | 42 | | 7 | TOB07 | PT | 111 |
| Condition 1 | 2171 |
| NICOTINE | Nicotine | 36.11 | mg/g | 36.11 | 36.11 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | Week 52 | 07-19-2023 | Week 24 | 39 | | 8 | TOB07 | PT | 111 |
| Condition 1 | 218 | 1 |
| 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 5224 | 93 | | 9 | TOB07 | PT | 111 |
| Condition 1 | 219 | 1 |
| NICOTINE | Nicotine | 35.54 | mg/g | 35.54 | 35.54 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | Week 52 | 07-19-2023 | Week 24 | 39 | | 10 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2203 | 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 | 2213 | 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 | 2223 | 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 | 2233 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1242 | mg/PUFF | 0.1242 | 0.1242 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 24 | 03-29-2023 | Week 8 | 24 | | 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2243 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1084 | mg/PUFF | 0.1084 | 0.1084 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 24 | 03-29-2023 | Week 8 | 24 | | 15 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2253 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1174 | mg/PUFF | 0.1174 | 0.1174 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 24 | 03-29-2023 | Week 8 | 24 | | 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2263 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1374 | mg/PUFF | 0.1374 | 0.1374 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 52 | 07-19-2023 | Week 24 | 39 | | 17 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2273 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1364 | mg/PUFF | 0.1364 | 0.1364 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 52 | 07-19-2023 | Week 24 | 39 | | 18 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2283 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1264 | mg/PUFF | 0.1264 | 0.1264 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 52 | 07-19-2023 | Week 24 | 39 | | 19 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 2293 | 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 | 2304 | 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 | 2314 | 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 | 2324 | 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 248 | 42 | | 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 2334 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1134 | mg/PUFF | 0.1134 | 0.1134 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 24 | 03-29-2023 | Week 8 | 24 | | 24 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 2344 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1125 | mg/PUFF | 0.1125 | 0.1125 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 24 | 03-29-2023 | Week 8 | 24 | | 25 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 2354 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1156 | mg/PUFF | 0.1156 | 0.1156 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 52 | 07-19-2023 | Week 24 | 39 | | 26 | TOB07 | PT | 111111 | PUFFMASTER3K | Condition 3 | 2364 | 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 5224 | 93 | | 27 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 2374 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1157 | mg/PUFF | 0.1157 | 0.1157 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 52 | 07-19-2023 | Week 24 | 39 |
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Details of the storage conditions are represented in the Environmental Storage Conditions ( 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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