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Tobacco product stabilities are conducted to assess changes in the properties, characteristics and constituents of a product over the course of the shelf-life after manufacture. Any changes of a product over time may affect the health risks of product use.

Measures of stability may include microbial stability, chemical stability, product component stability (i.e. battery), container closure stability (i.e. leachability), etc.

Stability studies of tobacco products would typically require testing for constituents and parameters in multiple replicates over multiple timepoints throughout the study, and possibly under multiple different sets of storage conditions. Such studies will result in datasets that can be quite large. In order to demonstrate the concepts in more concise datasets, each of the two SDTM examples below illustrates stability studies in two parts: 1) a dataset that shows results from testing of multiple constituents at one replicate, one timepoint, under one set of environmental storage conditions, and 2) a dataset that shows what the results would look like for testing of one constituent at three replicates, three timepoints, and two different sets of storage conditions. The examples demonstrate these concepts for an ENDS tobacco product (Example 1) and a smokeless tobacco product (Example 2). Additionally, an analysis dataset example is provided for the smokeless tobacco product to illustrate the representation of some common statistics using the CDISC ADaM standard.

Example

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.

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.

  • 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).

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.

pt.xpt

pt.xpt

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
5TOB07PT111
Condition 15
GLYCRLGlycerolSTABILITY TESTINGPrimary Ingredient615.68mg/g
615.68615.68mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
6TOB07PT111PUFFMASTER3KCondition 16NON-INTENSE REGIMENGLYCRLGlycerolSTABILITY TESTINGPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
7TOB07PT111
Condition 17
PRPYLGLYPropylene GlycolSTABILITY TESTINGPrimary Ingredient218.21mg/g
218.21218.21mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
8TOB07PT111PUFFMASTER3KCondition 18NON-INTENSE REGIMENPRPYLGLYPropylene GlycolSTABILITY TESTINGPrimary Ingredient0.8565mg/PUFF0.000240.85650.8565mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
9TOB07PT111
Condition 19
BNZOICACBenzoic AcidSTABILITY TESTINGAcid42.2ug/PUFF
42.242.2ug/PUFFTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
10TOB07PT111
Condition 110
MENTHOLMentholSTABILITY TESTINGFlavorant37.53mg/g
37.5337.53mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
11TOB07PT111PUFFMASTER3KCondition 111NON-INTENSE REGIMENMENTHOLMentholSTABILITY TESTINGFlavorant0.5881mg/PUFF0.000240.58810.5881mg/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
12TOB07PT111PUFFMASTER3KCondition 112NON-INTENSE REGIMENGLYCDOLGlycidolSTABILITY TESTINGStabilizerNOT DETECTED
0.00011NOT DETECTED

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
13TOB07PT111PUFFMASTER3KCondition 113NON-INTENSE REGIMENFRMLDHDFormaldehydeSTABILITY TESTING
0.0728ug/PUFF0.005490.07280.0728ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
14TOB07PT111PUFFMASTER3KCondition 114NON-INTENSE REGIMENACROLNAcrolienSTABILITY TESTING
DETECTED, BELOW LLOQ
0.00928DETECTED, BELOW LLOQ

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
15TOB07PT111
Condition 115
LACTICACLactic AcidSTABILITY TESTING
40.44ug/g
40.4440.44ug/gTPT LABCOTLEL01_v1.5.pdf

E-LIQUID

0.001102-01-2023Week 01
16TOB07PT111PUFFMASTER3KCondition 116NON-INTENSE REGIMENLACTICACLactic AcidSTABILITY TESTING
29.71ug/PUFF0.28429.7129.71ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
17TOB07PT111
Condition 117
VANLLNVanillinSTABILITY TESTINGFlavorant1.12ug/g
1.121.12ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
18TOB07PT111
Condition 118
NNKNicotine-Derived Nitrosamine KetoneSTABILITY TESTINGHPHC0.0711ug/g
0.07110.0711ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
19TOB07PT111
Condition 119
NNNN-NitrosonornicotineSTABILITY TESTINGHPHC0.0852ug/g
0.08520.0852ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
20TOB07PT111PUFFMASTER3KCondition 120NON-INTENSE REGIMENNNKNicotine-Derived Nitrosamine KetoneSTABILITY TESTINGHPHC0.0577ug/PUFF
0.05770.0577ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
21TOB07PT111PUFFMASTER3KCondition 121NON-INTENSE REGIMENNNNN-NitrosonornicotineSTABILITY TESTINGHPHC0.0742ug/PUFF
0.07420.0742ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
22TOB07PT111
Condition 122
NICKELNickelSTABILITY TESTINGExtractables / Leachables0.0897ug/g
0.08970.0897ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
23TOB07PT111PUFFMASTER3KCondition 123NON-INTENSE REGIMENMASSMassSTABILITY TESTING
3.87mg/PUFF0.00713.873.87mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
24TOB07PT111
Condition 124
CHROMIUMChromiumSTABILITY TESTING
NOT DETECTED

NOT DETECTED

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

pH

STABILITY TESTING
7.15

7.157.15
TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
26TOB07PT111PUFFMASTER3KCondition 126NON-INTENSE REGIMENPHpHSTABILITY TESTING
7.24

7.247.24
TPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
27TOB07PT111
Condition 127
ENDTXNEndotoxinSTABILITY TESTINGToxinsNOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
28TOB07PT111
Condition 128
AEBCTAerobic Colony CountSTABILITY TESTINGMicrobiological<1CFU/mL
<1
CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
29TOB07PT111
Condition 129
YSTMLDCTYeast and/or Mold Colony CountSTABILITY TESTINGMicrobiological1CFU/mL
11CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
30TOB07PT111
Condition 130
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
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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. 

  • 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.

pt.xpt

pt.xpt

Row

STUDYID

DOMAINSPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PT111
Condition 1211
NICOTINE

Nicotine

35.94mg/g35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID102-01-2023Week 01
2TOB07PT111
Condition 1212


NICOTINE

Nicotine35.46mg/g35.4635.46mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID202-01-2023Week 01
3TOB07PT111
Condition 1213
NICOTINENicotine35.97mg/g35.9735.97mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID302-01-2023Week 01
4TOB07PT111
Condition 1214
NICOTINENicotine35.55mg/g35.5535.55mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID103-29-2023Week 82
5TOB07PT111
Condition 1215
NICOTINENicotine35.88mg/g35.8835.88mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID203-29-2023Week 82
6TOB07PT111
Condition 1216
NICOTINENicotine35.67mg/g35.6735.67mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID303-29-2023Week 82
7TOB07PT111
Condition 1217
NICOTINENicotine36.11mg/g36.1136.11mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID107-19-2023Week 243
8TOB07PT111
Condition 1218
NICOTINENicotine35.72mg/g35.7235.72mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID207-19-2023Week 243
9TOB07PT111
Condition 1219
NICOTINENicotine35.54mg/g35.5435.54mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID307-19-2023Week 243
10TOB07PT111PUFFMASTER3KCondition 2220NON-INTENSE REGIMENNICOTINE

Nicotine

0.1039mg/PUFF0.10390.1039mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL102-01-2023Week 01
11TOB07PT111PUFFMASTER3KCondition 2221NON-INTENSE REGIMENNICOTINENicotine0.1142mg/PUFF0.11420.1142mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL202-01-2023Week 01
12TOB07PT111PUFFMASTER3KCondition 2222NON-INTENSE REGIMENNICOTINENicotine0.1282mg/PUFF0.12820.1282mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL302-01-2023Week 01
13TOB07PT111PUFFMASTER3KCondition 2223NON-INTENSE REGIMENNICOTINENicotine0.1242mg/PUFF0.12420.1242mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL103-29-2023Week 82
14TOB07PT111PUFFMASTER3KCondition 2224NON-INTENSE REGIMENNICOTINENicotine0.1084mg/PUFF0.10840.1084mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL203-29-2023Week 82
15TOB07PT111PUFFMASTER3KCondition 2225NON-INTENSE REGIMENNICOTINENicotine0.1174mg/PUFF0.11740.1174mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL303-29-2023Week 82
16TOB07PT111PUFFMASTER3KCondition 2226NON-INTENSE REGIMENNICOTINENicotine0.1374mg/PUFF0.13740.1374mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL107-19-2023Week 243
17TOB07PT111PUFFMASTER3KCondition 2227NON-INTENSE REGIMENNICOTINENicotine0.1364mg/PUFF0.13640.1364mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL207-19-2023Week 243
18TOB07PT111PUFFMASTER3KCondition 2228NON-INTENSE REGIMENNICOTINENicotine0.1264mg/PUFF0.12640.1264mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL307-19-2023Week 243
19TOB07PT111PUFFMASTER3KCondition 2229NON-INTENSE REGIMENNICOTINENicotine0.1256mg/PUFF0.12560.1256mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL102-01-2023Week 01
20TOB07PT111PUFFMASTER3KCondition 3230NON-INTENSE REGIMENNICOTINENicotine0.1236mg/PUFF0.12360.1236mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL202-01-2023Week 01
21TOB07PT111PUFFMASTER3KCondition 3231NON-INTENSE REGIMENNICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL302-01-2023Week 01
22TOB07PT111PUFFMASTER3KCondition 3232NON-INTENSE REGIMENNICOTINENicotine0.1334mg/PUFF0.13340.1334mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL103-29-2023Week 82
23TOB07PT111PUFFMASTER3KCondition 3233NON-INTENSE REGIMENNICOTINENicotine0.1134mg/PUFF0.11340.1134mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL203-29-2023Week 82
24TOB07PT111PUFFMASTER3KCondition 3234NON-INTENSE REGIMENNICOTINENicotine0.1125mg/PUFF0.11250.1125mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL303-29-2023Week 82
25TOB07PT111PUFFMASTER3KCondition 3235NON-INTENSE REGIMENNICOTINENicotine0.1156mg/PUFF0.11560.1156mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL107-19-2023Week 243
26TOB07PT111PUFFMASTER3KCondition 3236NON-INTENSE REGIMENNICOTINENicotine0.1145mg/PUFF0.11450.1145mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL207-19-2023Week 243
27TOB07PT111PUFFMASTER3KCondition 3237NON-INTENSE REGIMENNICOTINENicotine0.1157mg/PUFF0.11570.1157mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL307-19-2023Week 243
$warningHtml

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.

es.xpt

es.xpt

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
$warningHtml


Example 2, below, demonstrates stability studies using constituents/parameters applicable to a smokeless tobacco product.

Example

The first PT dataset shows 7 constituents/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 of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because their results are reported two separate ways: once for the result as tested and once where the result is expressed as dry weight basis (the latter is indicated by PTTSTDTL = DRY WEIGHT BASIS). Note that the constituent/parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

  • 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 ES dataset example that follows the 2 PT dataset examples. 
  • 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/parameter when such methodology is too complex for the single PTMETHOD variable.

Row 1:

Shows the PTTEST of Moisture Content, which reflects the percentage of moisture in the substance for the condition noted in STOCONID (i.e., Condition 1). Moisture Content is used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Moisture Content (see row 3).

Rows 4, 6:Show the NNK and NNN tests with the results from the tobacco product as tested.
Rows 5, 7:Show the NNK and NNN test results as dry weight basis (DWB). Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-3, 8-9:

Show the other analytes measured in testing.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 11MOISTCTTMoisture Content
STABILITY TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 12PHpH
STABILITY TESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023Week 01
3TOB07PTSmokeless01Condition 13H2OACTWater Activity
STABILITY TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023Week 01
4TOB07PTSmokeless01Condition 14NNKNicotine-Derived Nitrosamine Ketone
STABILITY TESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
5TOB07PTSmokeless01Condition 15NNKNicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
6TOB07PTSmokeless01Condition 16NNNN-Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
8TOB07PTSmokeless01Condition 18AEBCTAerobic Colony Count
STABILITY TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
9TOB07PTSmokeless01Condition 19YSTMLDCTYeast and/or Mold Colony Count
STABILITY TESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The second PT dataset shows testing for just 1 parameter (Moisture Content), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study. 

  • Details of the storage conditions are represented in the ES dataset example that follows.

Rows 1-9:

Show the results of testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 1" (STOCONID).

Rows 10-18:Show the results of testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID).

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1111MOISTCTTMoisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 1112MOISTCTTMoisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
3TOB07PTSmokeless01Condition 1113MOISTCTTMoisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07PTSmokeless01Condition 1114MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
5TOB07PTSmokeless01Condition 1115MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
6TOB07PTSmokeless01Condition 1116MOISTCTTMoisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
7TOB07PTSmokeless01Condition 1117MOISTCTTMoisture Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
8TOB07PTSmokeless01Condition 1118MOISTCTTMoisture Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9TOB07PTSmokeless01Condition 1119MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
10TOB07PTSmokeless01Condition 2120MOISTCTTMoisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07PTSmokeless01Condition 2121MOISTCTTMoisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07PTSmokeless01Condition 2122MOISTCTTMoisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07PTSmokeless01Condition 2123MOISTCTTMoisture Content51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
14TOB07PTSmokeless01Condition 2124MOISTCTTMoisture Content51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
15TOB07PTSmokeless01Condition 2125MOISTCTTMoisture Content51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
16TOB07PTSmokeless01Condition 2126MOISTCTTMoisture Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
17TOB07PTSmokeless01Condition 2127MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
18TOB07PTSmokeless01Condition 2128MOISTCTTMoisture Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 both sets of storage conditions used across both of the PT dataset examples.

es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C
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Example

The following example illustrates calculation of some of the statistics typically calculated on product stability measures.

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adpt.xpt

RowSTUDYIDPRODSTIDSPTOBIDSTOCONIDPARQUALPARAMPARAMCDAVALATPTATPTN
1TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE51.95667Week 01
2TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD0.025166Week 01
3TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)% RSDPCTRSD0.048437Week 01
4TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE51.72333Week 82
5TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD0.046188Week 82
6TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)% RSDPCTRSD0.089298Week 82
7TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE52.31333Week 243
8TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD0.327465Week 243
9TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)% RSDPCTRSD0.625969Week 243
10TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE51.95667Week 01
11TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)S.D.STD0.025166Week 01
12TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.048437Week 01
13TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE51.80333Week 82
14TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)S.D.STD0.035119Week 82
15TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.067793Week 82
16TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE52.08667Week 243
17TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)S.D.STD0.188237Week 243
18TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.361393Week 243
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ADPT Dataset Metadata

ADPT Variable Metadata

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