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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.

Info

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.

Note
  • 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).
Dataset wrap
Namept
Rowcaps
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.
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PT111
Condition 1

1


NICOTINENicotineSTABILITY TESTING
35.94mg/g
35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
2TOB07PT111PUFFMASTER3KCondition 12NON-INTENSE REGIMENNICOTINENicotineSTABILITY TESTING

0.1039

mg/PUFF
0.10390.1039mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
3TOB07PT111
Condition 13
NORNCTN

Nornicotine

STABILITY TESTINGNicotine Degradant25.76ug/g
25.7625.76ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
4TOB07PT111PUFFMASTER3KCondition 14NON-INTENSE REGIMENNORNCTN

Nornicotine

STABILITY TESTINGNicotine Degradant0.0392ug/PUFF
0.03920.0392ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
5
Warning

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.

Info

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 (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.

Info

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? Thanks.

Dataset wrap
Namept
2
Rowcaps
Rows 1-20:Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is Condition 1. 
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 PTSCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is Condition 1.  
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT111Condition 1

1

VAP77777.1NICOTINENicotineSTABILITY STUDY35.94mg/g35.9435.94mg/gE-LIQUID1Week 01
TOB07PT111
Condition 1
2
5
VAP77777.1

GLYCRL
NICOTINE
Glycerol
NicotineSTABILITY STUDY
STABILITY TESTINGPrimary Ingredient615.68
0.1039
mg/
PUFF
g
0

615.
1039
68
0
615.
1039
68mg/
PUFFAEROSOL
gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
3
6TOB07PT111PUFFMASTER3KCondition 1
3VAP77777.1NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant25.76ug/g25.7625.76ug/gE-LIQUID
6NON-INTENSE REGIMENGLYCRLGlycerolSTABILITY TESTINGPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023
1
Week 01
4
7TOB07PT111
Condition
13VAP77777.
1
NORNCTN
7
PRPYLGLYPropylene Glycol
Nornicotine
STABILITY
STUDY
TESTING
Nicotine Degradant
Primary Ingredient
0
218.
0392
21
ug
mg/
PUFF
g
0

218.
0392
21
0
218.
0392
21
ug/PUFFAEROSOL
mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023
1
Week 01
5
8TOB07PT111PUFFMASTER3KCondition 1
5VAP77777.1GLYCRLGlycerol
8NON-INTENSE REGIMENPRPYLGLYPropylene GlycolSTABILITY TESTING
STABILITY STUDY
Primary Ingredient
615
0.
68
8565mg/
g615.68615.68mg/gE-LIQUID
PUFF0.000240.85650.8565mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023
1
Week 01
6
9TOB07PT111
Condition 1
5VAP77777.1GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFAEROSOL1
9
BNZOICACBenzoic AcidSTABILITY TESTINGAcid42.2ug/PUFF
42.242.2ug/PUFFTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
7
10TOB07PT111
Condition 1
6
10
VAP77777.1PRPYLGLY

MENTHOLMenthol
Propylene Glycol
STABILITY
STUDY
TESTING
Primary Ingredient
Flavorant
218
37.
21
53mg/g
218

37.
21
53
218
37.
21
53mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
8
11TOB07PT111PUFFMASTER3KCondition 1
6VAP77777.1PRPYLGLYPropylene GlycolSTABILITY STUDY
11NON-INTENSE REGIMENMENTHOLMentholSTABILITY TESTINGFlavorant
Primary Ingredient
0.
8565
5881mg/PUFF0.000240.
8565
58810.
8565
5881mg/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
9
12TOB07PT111PUFFMASTER3KCondition 1
7VAP77777.1BNZOICACBenzoic AcidSTABILITY STUDYAcidE-LIQUID
12NON-INTENSE REGIMENGLYCDOLGlycidolSTABILITY TESTINGStabilizerNOT DETECTED
0.00011NOT DETECTED

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023
1
Week 01
10
13TOB07PT111PUFFMASTER3KCondition 1
8VAP77777.1MENTHOLMentholSTABILITY STUDYFlavorant37.53mg/g37.5337.53mg/gE-LIQUID
13NON-INTENSE REGIMENFRMLDHDFormaldehydeSTABILITY TESTING
0.0728ug/PUFF0.005490.07280.0728ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023
1
Week 01
11
14TOB07PT111PUFFMASTER3KCondition 1
8VAP77777.1MENTHOLMentholSTABILITY STUDY
14NON-INTENSE REGIMENACROLNAcrolienSTABILITY TESTING
DETECTED, BELOW LLOQ
Flavorant

0.
5881mg/PUFF0.000240.58810.5881mg/PUFF

AEROSOL

1
00928DETECTED, BELOW LLOQ

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
12
15TOB07PT111
Condition 1
VAP77777.1GLYCDOLGlycidolSTABILITY STUDYStabilizer<Limit of Detection (LOD)0.00011<Limit of detection (LOD)

AEROSOL

1
15
LACTICACLactic AcidSTABILITY TESTING
40.44ug/g
40.4440.44ug/gTPT LABCOTLEL01_v1.5.pdf

E-LIQUID

0.001102-01-2023Week 01
13
16TOB07PT111PUFFMASTER3KCondition 1
VAP77777.1FormaldehydeSTABILITY STUDY
16NON-INTENSE REGIMENLACTICACLactic AcidSTABILITY TESTING
29.71
0.0728
ug/PUFF0.
00549
284
0
29.
0728
71
0.0728ug/PUFF

AEROSOL

1Week 0114TOB07PT111Condition 1VAP77777.1AcrolienSTABILITY STUDY<Limit of Quantification (LOQ)0.00928Limit of Quantification (LOQ)

AEROSOL

29.71ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023
1
Week 01
15
17TOB07PT111
Condition 117
VAP77777.1

VANLLNVanillin
Lactic Acid
STABILITY
STUDY
TESTINGFlavorant
40
1.
44
12ug/g
40

1.
44
12
40
1.
44
12ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
16
18TOB07PT111
Condition 1
VAP77777.1Lactic AcidSTABILITY STUDY29.71ug/PUFF0.28429.7129.71ug/PUFF

AEROSOL

18
NNKNicotine-Derived Nitrosamine KetoneSTABILITY TESTINGHPHC0.0711ug/g
0.07110.0711ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023
118
Week 01
17
19TOB07PT111
Condition 1
9VAP77777.1VANLLNVanillinSTABILITY STUDYFlavorant
19
NNNN-NitrosonornicotineSTABILITY TESTINGHPHC0.0852ug/g
0.08520.0852ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
19
20TOB07PT111PUFFMASTER3KCondition 1
10
20NON-INTENSE REGIMEN
VAP77777.1
NNKNicotine-Derived Nitrosamine KetoneSTABILITY
STUDY
TESTINGHPHC
E-LIQUID1
0.0577ug/PUFF
0.05770.0577ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
20
21TOB07PT111PUFFMASTER3KCondition 1
11
21NON-INTENSE REGIMEN
VAP77777.1
NNNN-NitrosonornicotineSTABILITY
STUDY
TESTINGHPHC
E-LIQUID1Week 01
0.0742ug/PUFF
0.07420.0742ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023
21TOB07PT111Condition 112VAP77777.1NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHCAEROSOL1
Week 01
22TOB07PT111
Condition 1
13
22
VAP77777.1NNN

NICKELNickel
N-Nitrosonornicotine
STABILITY
STUDY
TESTING
HPHCAEROSOL1Week 0123TOB07PT111Condition 114VAP77777.1NICKELNickelSTABILITY STUDY
Extractables / Leachables0.0897ug/g
0.08970.0897ug/gTPT LABCOTLEL01_v1.5.pdf
Extractables / Leachables 
E-LIQUID0.001102-01-2023Week 01
24
23TOB07PT111PUFFMASTER3KCondition 1
14
23NON-INTENSE REGIMEN
VAP77777.1
MASSMassSTABILITY
STUDY
TESTING
3.87mg/PUFF0.00713.873.87mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL
1
0.001102-01-2023Week 01
25
24TOB07PT111
Condition 1
14
24
VAP77777.1

CHROMIUMChromiumSTABILITY
STUDY
TESTING
NOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
26
25TOB07PT111
Condition 125
PH

pH

STABILITY TESTING
7.15
VAP77777


7.
1
15
PHpH
7.15
TPT LABCOTLEL01_v1.5.pdf
STABILITY STUDY
E-LIQUID0.001102-01-2023Week 01
27
26TOB07PT111PUFFMASTER3KCondition 1
15
26NON-INTENSE REGIMEN
VAP77777.1
PHpHSTABILITY
STUDY
TESTING
AEROSOL1Week 0128TOB07PT111Condition 116VAP77777.1ENDTXNEndotoxinSTABILITY STUDYToxinsE-LIQUID1

7.24

7.247.24
TPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
29
27TOB07PT111
Condition 1
17
27
VAP77777.1

ENDTXN
AEBPLCT
Endotoxin
Aerobic Plate Count
STABILITY
STUDY
TESTING
Microbiological
Toxins
<1 CFU/mL<1 <1 
NOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdf
CFU/mL
E-LIQUID0.001102-01-2023Week 01
30
28TOB07PT111
Condition 1
18
28
VAP77777.1TYMCTotal Yeast and/or Mold

AEBCTAerobic Colony CountSTABILITY
STUDY
TESTINGMicrobiological
11
<1CFU/mL
1

<1
CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
31
29TOB07
PT111Condition 119VAP77777.1ACTALDAcetaldehydeSTABILITY STUDYAldehydeE-LIQUID1
PT111
Condition 129
YSTMLDCTYeast and/or Mold Colony CountSTABILITY TESTINGMicrobiological1CFU/mL
11CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
32
30TOB07PT111
Condition 1
20VAP77777.1ACTPROPNAcetyl PropionylSTABILITY STUDYDiketoneE-LIQUID1Week 01

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.

30
ACTALDAcetaldehydeSTABILITY TESTINGAldehyde7.8ug/mL
7.87.8ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
31TOB07PT111
Condition 131
ACTPROPNAcetyl PropionylSTABILITY TESTINGDiketone32.4ug/mL
32.432.4ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
Info

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. 

Note
  • 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.
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.
Dataset wrap
Namept
Dataset wrap
Namept
Rowcaps
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:
Dataset2
Row

STUDYID

DOMAINSPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTGRPIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTNAMPTSPCCNDPTXFNPTMETHODPTSPECPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PT111
Condition 1211VAP77777.11
NICOTINE

Nicotine

35.94mg/mLg35.9435.94mg/mLgTPT LABCOTLEL01_v1.5.pdfE-LIQUID102-01-2023Week 01
2TOB07PT111
Condition 1212VAP77777.11

NICOTINE

Nicotinemg/mL


NICOTINE

Nicotine35.46mg/g35.4635.46mg/gTPT LABCOTLEL01_v1.5.pdfmg/mLE-LIQUID202-01-2023Week 01
3TOB07PT111
Condition 1213VAP77777.11
NICOTINENicotine35.97mg/mLg35.9735.97mg/mLE-LIQUID3gTPT LABCOTLEL01_v1.5.pdfE-LIQUID302-01-2023Week 01
4TOB07PT111
Condition 1214VAP77777.11
NICOTINENicotine35.55mg/mLg35.5535.55mg/mLgTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 2403-29-2023Week 824
5TOB07PT111
Condition 1215VAP77777.11
NICOTINENicotine35.88mg/mLg35.8835.88mg/mLgTPT LABCOTLEL01_v1.5.pdfE-LIQUID203-29-2023Week 24842
6TOB07PT111
Condition 1216VAP77777.11
NICOTINENicotine35.67mg/mLg35.6735.67mg/mLgTPT LABCOTLEL01_v1.5.pdfE-LIQUID303-29-2023Week 24842
7TOB07PT111
Condition 1217VAP77777.11
NICOTINENicotine36.11mg/mLg36.1136.11mg/mLgTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 5207-19-2023Week 2439
8TOB07PT111
Condition 1218VAP77777.11NICOTINENicotinemg/mL
NICOTINENicotine35.72mg/g35.7235.72mg/gTPT LABCOTLEL01_v1.5.pdfmg/mLE-LIQUID207-19-2023Week 522493
9TOB07PT111
Condition 1219VAP77777.11
NICOTINENicotine35.54mg/mLg35.5435.54mg/mLgTPT LABCOTLEL01_v1.5.pdfE-LIQUID307-19-2023Week 522493
10TOB07PT111111PUFFMASTER3KCondition 2220VAP77777.13NON-INTENSE REGIMENNICOTINE

Nicotine

0.1039mg/puffPUFF0.10390.1039mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL102-01-2023Week 01
11TOB07PT111PUFFMASTER3KCondition 2221VAP77777.13NICOTINENON-INTENSE REGIMENNICOTINENicotine0.1142mg/PUFF0.11420.1142Nicotinemg/puffmg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL202-01-2023Week 01
12TOB07PT111PUFFMASTER3KCondition 2222VAP77777.13NON-INTENSE REGIMENNICOTINENicotine0.1282mg/puffPUFF0.12820.1282mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL302-01-2023Week 01
13TOB07PT111PUFFMASTER3KCondition 2223VAP77777.1NON-INTENSE REGIMEN3NICOTINENicotine0.1242mg/puffPUFF0.12420.1242mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 2403-29-2023Week 824
14TOB07PT111PUFFMASTER3KCondition 2224VAP77777.13NICOTINENON-INTENSE REGIMENNICOTINENicotine0.1084mg/PUFF0.10840.1084Nicotinemg/puffmg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL203-29-2023Week 24842
15TOB07PT111PUFFMASTER3KCondition 2225VAP77777.13NON-INTENSE REGIMENNICOTINENicotine0.1174mg/puffPUFF0.11740.1174mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL303-29-2023Week 24842
16TOB07PT111PUFFMASTER3KCondition 2226VAP77777.13NON-INTENSE REGIMENNICOTINENicotine0.1374mg/puffPUFF0.13740.1374mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 5207-19-2023Week 2439
17TOB07PT111PUFFMASTER3KCondition 2227VAP77777.13NICOTINENON-INTENSE REGIMENNICOTINENicotine0.1364mg/PUFF0.13640.1364Nicotinemg/puffmg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 5207-19-2023Week 2439
18TOB07PT111PUFFMASTER3KCondition 2228VAP77777.13NICOTINENON-INTENSE REGIMENNICOTINENicotine0.1264mg/PUFF0.12640.1264Nicotinemg/puffmg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 5207-19-2023Week 2439
19TOB07PT111PUFFMASTER3KCondition 2229VAP77777.13NON-INTENSE REGIMENNICOTINENicotine0.1256mg/puffPUFF0.12560.1256mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL102-01-2023Week 01
20TOB07PT111PUFFMASTER3KCondition 3230VAP77777.14NON-INTENSE REGIMENNICOTINENicotine0.1236mg/puffPUFF0.12360.1236mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL202-01-2023Week 01
21TOB07PT111PUFFMASTER3KCondition 3231VAP77777.14NICOTINENicotinemg/puffmg/puffAEROSOL3NON-INTENSE REGIMENNICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL302-01-2023Week 01
22TOB07PT111PUFFMASTER3KCondition 3232VAP77777.14NON-INTENSE REGIMENNICOTINENicotine0.1334mg/puffPUFF0.13340.1334mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 2403-29-2023Week 824
23TOB07PT111PUFFMASTER3KCondition 3233VAP77777.1NON-INTENSE REGIMEN4NICOTINENicotine0.1134mg/puffPUFF0.11340.1134mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 2403-29-2023Week 824
24TOB07PT111PUFFMASTER3KCondition 3234VAP77777.14NICOTINENON-INTENSE REGIMENNICOTINENicotine0.1125mg/PUFF0.11250.1125Nicotinemg/puffmg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL303-29-2023Week 24842
25TOB07PT111PUFFMASTER3KCondition 3235VAP77777.14NON-INTENSE REGIMENNICOTINENicotine0.1156mg/puffPUFF0.11560.1156mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL107-19-2023Week 522493
26TOB07PT111PUFFMASTER3KCondition 3236VAP77777.14NON-INTENSE REGIMENNICOTINENicotine0.1145mg/puffPUFF0.11450.1145mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 5207-19-2023Week 2439
27TOB07PT111PUFFMASTER3KCondition 3237VAP77777.14NICOTINENON-INTENSE REGIMENNICOTINENicotine0.1157mg/PUFF0.11570.1157Nicotinemg/puffmg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 5207-19-2023Week 2439

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.

Dataset wrap
Namees
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity60%
4

TOB07

ESCondition 22TEMPTemperature27C
5

TOB07

ESCondition 31HUMIDHumidity95%
6

TOB07

ESCondition 32TEMPTemperature31C