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The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the PT domain, with PTCAT = STABILITY STUDY.
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The first dataset shows 12 constituents each 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 set of storage conditions 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 (PT) 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.
Question: For laboratory's limit of detection (LOD), limit of quantification (LOQ); Should we have --ORNRLO = Reference Range Lower Limit in Orig Unit; and --ORNRHI = Reference Range Upper Limit in Orig Unit? There is a variable --LLOD = Lower Limit of Detection. Added this for LOD. What should be used for LOQ? Thanksconstruct an SDTM-conformant PT dataset for a stability study. 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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| 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. |
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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 | TOB07 | PT | 111 |
| Condition 1 | 2 | NICOTINE | Nicotine | STABILITY STUDY |
| | mg/PUFF |
| 0.1039 | 0.1039 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 3 | TOB07 | PT | 111 |
| Condition 1 | 3 | NORNCTN | | STABILITY STUDY | Nicotine Degradant | 25.76 | ug/g |
| 25.76 | 25.76 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 4 | TOB07 | PT | 111 |
| Condition 1 | 4 | NORNCTN | | STABILITY STUDY | Nicotine Degradant | 0.0392 | ug/PUFF |
| 0.0392 | 0.0392 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 5 | TOB07 | PT | 111 |
| Condition 1 | 5 | GLYCRL | Glycerol | STABILITY STUDY | Primary Ingredient | 615.68 | mg/g |
| 615.68 | 615.68 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 6 | TOB07 | PT | 111 |
| Condition 1 | 6 | GLYCRL | Glycerol | STABILITY STUDY | Primary Ingredient | 1.81 | mg/PUFF | 0.00144 | 1.81 | 1.81 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 7 | TOB07 | PT | 111 |
| Condition 1 | 7 | PRPYLGLY | Propylene Glycol | STABILITY STUDY | Primary Ingredient | 218.21 | mg/g |
| 218.21 | 218.21 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 8 | TOB07 | PT | 111 |
| Condition 1 | 8 | PRPYLGLY | Propylene Glycol | STABILITY STUDY | Primary Ingredient | 0.8565 | mg/PUFF | 0.00024 | 0.8565 | 0.8565 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 9 | TOB07 | PT | 111 |
| Condition 1 | 9 | BNZOICAC | Benzoic Acid | STABILITY STUDY | Acid | 42.2 | ug/PUFF |
| 42.2 | 42.2 | ug/PUFF | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 10 | TOB07 | PT | 111 |
| Condition 1 | 10 | MENTHOL | Menthol | STABILITY STUDY | Flavorant | 37.53 | mg/g |
| 37.53 | 37.53 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 11 | TOB07 | PT | 111 |
| Condition 1 | 11 | MENTHOL | Menthol | STABILITY STUDY | Flavorant | 0.5881 | mg/PUFF | 0.00024 | 0.5881 | 0.5881 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 12 | TOB07 | PT | 111 |
| Condition 1 | 12 | GLYCDOL | Glycidol | STABILITY STUDY | Stabilizer | NOT DETECTED |
| 0.00011 | NOT DETECTED |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 13 | TOB07 | PT | 111 |
| Condition 1 | 13 | FRMLDHD | Formaldehyde | STABILITY STUDY |
| 0.0728 | ug/PUFF | 0.00549 | 0.0728 | 0.0728 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 14 | TOB07 | PT | 111 |
| Condition 1 | 14 | ACROLN | Acrolien | STABILITY STUDY |
| DETECTED, BELOW LLOQ |
| 0.00928 | DETECTED, BELOW LLOQ |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 15 | TOB07 | PT | 111 |
| Condition 1 | 15 | LACTICAC | Lactic Acid | STABILITY STUDY |
| 40.44 | ug/g |
| 40.44 | 40.44 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 16 | TOB07 | PT | 111 |
| Condition 1 | 16 | LACTICAC | Lactic Acid | STABILITY STUDY |
| 29.71 | ug/PUFF | 0.284 | 29.71 | 29.71 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 17 | TOB07 | PT | 111 |
| Condition 1 | 17 | VANLLN | Vanillin | STABILITY STUDY | Flavorant | 1.12 | ug/g |
| 1.12 | 1.12 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 18 | TOB07 | PT | 111 |
| Condition 1 | 18 | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | HPHC | 0.0711 | ug/g |
| 0.0711 | 0.0711 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 19 | TOB07 | PT | 111 |
| Condition 1 | 19 | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | 0.0852 | ug/g |
| 0.0852 | 0.0852 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 20 | TOB07 | PT | 111 |
| Condition 1 | 20 | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | HPHC | 0.0577 | ug/PUFF |
| 0.0577 | 0.0577 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 21 | TOB07 | PT | 111 |
| Condition 1 | 21 | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | 0.0742 | ug/PUFF |
| 0.0742 | 0.0742 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 22 | TOB07 | PT | 111 |
| Condition 1 | 22 | NICKEL | Nickel | STABILITY STUDY | Extractables / Leachables | 0.0897 | ug/g |
| 0.0897 | 0.0897 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 23 | TOB07 | PT | 111 |
| Condition 1 | 23 | MASS | Mass | STABILITY STUDY |
| 3.87 | mg/PUFF | 0.0071 | 3.87 | 3.87 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 24 | TOB07 | PT | 111 |
| Condition 1 | 24 | CHROMIUM | Chromium | STABILITY STUDY |
| NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 25 | TOB07 | PT | 111 |
| Condition 1 | 25 | PH | pH | STABILITY STUDY |
| 7.15 |
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| 7.15 | 7.15 |
| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 26 | TOB07 | PT | 111 |
| Condition 1 | 26 | PH | pH | STABILITY STUDY |
| 7.24 |
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| 7.24 | 7.24 |
| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | Week 0 | 1 | | 27 | TOB07 | PT | 111 |
| Condition 1 | 27 | ENDTXN | Endotoxin | STABILITY STUDY | Toxins | NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 28 | TOB07 | PT | 111 |
| Condition 1 | 28 | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | Microbiological | <1 | CFU/mL |
| <1 |
| CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 29 | TOB07 | PT | 111 |
| Condition 1 | 29 | TYMC | Total Yeast and/or Mold Count | STABILITY STUDY | Microbiological | 1 | CFU/mL |
| 1 | 1 | CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 30 | TOB07 | PT | 111 |
| Condition 1 | 30 | ACTALD | Acetaldehyde | STABILITY STUDY | Aldehyde | 7.8 | ug/mL |
| 7.8 | 7.8 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 | | 31 | TOB07 | PT | 111 |
| Condition 1 | 31 | ACTPROPN | Acetyl Propionyl | STABILITY STUDY | Diketone | 32.4 | ug/mL |
| 32.4 | 32.4 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | Week 0 | 1 |
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