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This example will need to be udated following the ENDS stability study approach, which was created to reflect recent developments and consultation with CDISC ISMT


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

Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqPT.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqN/A
TRTPPlanned TreatmentChar
CondN/A
TRTAActual TreatmentChar
CondN/A
PARQUAL




PARAMParameterChar
Req
PARAMCDParameter Codetext
Req
PARCAT1Parameter Category 1Char
PermPT.PTCAT
AVALAnalysis ValueNum
Condsee parameter level metadata
PTSEQSequence NumberNum
PermPT.PTSEQ

ADPT

STUDYIDSPTOBIDPTREFIDPARQUALPARAMPARAMCDAVALPTTSTCNDPTSEQ
TOB07Smokeless01TOB77777.1Product Moisture (%)AverageAVERAGE
Condition 1 (X°C/ Z% RH)1
TOB07Smokeless01TOB77777.1Product Moisture (%)S.D.STD
Condition 1 (X°C/ Z% RH)1
TOB07Smokeless01TOB77777.1Product Moisture (%)% RSDPCTRSD
Condition 1 (X°C/ Z% RH)1
TOB07Smokeless01TOB77777.1pHAverageAVERAGE
Condition 1 (X°C/ Z% RH)2
TOB07Smokeless01TOB77777.1pHS.D.STD
Condition 1 (X°C/ Z% RH)2
TOB07Smokeless01TOB77777.1pH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)2
TOB07Smokeless01TOB77777.1Water ActivityAverageAVERAGE
Condition 1 (X°C/ Z% RH)3
TOB07Smokeless01TOB77777.1Water ActivityS.D.STD
Condition 1 (X°C/ Z% RH)3
TOB07Smokeless01TOB77777.1Water Activity% RSDPCTRSD
Condition 1 (X°C/ Z% RH)3
TOB07Smokeless01TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESHAverageAVERAGE
Condition 1 (X°C/ Z% RH)4
TOB07Smokeless01TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESHS.D.STD
Condition 1 (X°C/ Z% RH)4
TOB07Smokeless01TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)4
TOB07Smokeless01TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIEDAverageAVERAGE
Condition 1 (X°C/ Z% RH)5
TOB07Smokeless01TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIEDS.D.STD
Condition 1 (X°C/ Z% RH)5
TOB07Smokeless01TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED% RSDPCTRSD
Condition 1 (X°C/ Z% RH)5
TOB07Smokeless01TOB77777.1N-nitrosonornicotine) (ng/g) - FRESHAverageAVERAGE
Condition 1 (X°C/ Z% RH)6
TOB07Smokeless01TOB77777.1N-nitrosonornicotine) (ng/g) - FRESHS.D.STD
Condition 1 (X°C/ Z% RH)6
TOB07Smokeless01TOB77777.1N-nitrosonornicotine) (ng/g) - FRESH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)6
TOB07Smokeless01TOB77777.1N-nitrosonornicotine (ng/g) - DRIEDAverageAVERAGE
Condition 1 (X°C/ Z% RH)7
TOB07Smokeless01TOB77777.1N-nitrosonornicotine (ng/g) - DRIEDS.D.STD
Condition 1 (X°C/ Z% RH)7
TOB07Smokeless01TOB77777.1N-nitrosonornicotine (ng/g) - DRIED% RSDPCTRSD
Condition 1 (X°C/ Z% RH)7
TOB07Smokeless01TOB77777.1Tobacco-specific nitrosamines (ng/g) - FRESHAverageAVERAGE
Condition 1 (X°C/ Z% RH)8
TOB07Smokeless01TOB77777.1Tobacco-specific nitrosamines (ng/g) - FRESHS.D.STD
Condition 1 (X°C/ Z% RH)8
TOB07Smokeless01TOB77777.1Tobacco-specific nitrosamines (ng/g) - FRESH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)8
TOB07Smokeless01TOB77777.1Tobacco-specific nitrosamines (ng/g) - DRIEDAverageAVERAGE
Condition 1 (X°C/ Z% RH)9
TOB07Smokeless01TOB77777.1Tobacco-specific nitrosamines (ng/g) - DRIEDS.D.STD
Condition 1 (X°C/ Z% RH)9
TOB07Smokeless01TOB77777.1Tobacco-specific nitrosamines (ng/g) - DRIED% RSDPCTRSD
Condition 1 (X°C/ Z% RH)9
TOB07Smokeless01TOB77777.1Aerobic Plate CountAverageAVERAGE
Condition 1 (X°C/ Z% RH)10
TOB07Smokeless01TOB77777.1Aerobic Plate CountS.D.STD
Condition 1 (X°C/ Z% RH)10
TOB07Smokeless01TOB77777.1Aerobic Plate Count% RSDPCTRSD
Condition 1 (X°C/ Z% RH)10
TOB07Smokeless01TOB77777.1MoldAverageAVERAGE
Condition 1 (X°C/ Z% RH)11
TOB07Smokeless01TOB77777.1MoldS.D.STD
Condition 1 (X°C/ Z% RH)11
TOB07Smokeless01TOB77777.1Mold% RSDPCTRSD
Condition 1 (X°C/ Z% RH)11
TOB07Smokeless01TOB77777.1YeastAverageAVERAGE
Condition 1 (X°C/ Z% RH)12
TOB07Smokeless01TOB77777.1YeastS.D.STD
Condition 1 (X°C/ Z% RH)12
TOB07Smokeless01TOB77777.1Yeast% RSDPCTRSD
Condition 1 (X°C/ Z% RH)12
param1paramval1param2paramval2colvar1colvar2colvaltypcolvalcolvalucolord

shelf life factor

Product Moisture 

statistic

AverageCondition 1  (X°C/ Z% RH)Week 0

text?

xxx.x%

1

shelf life factor

Product Moisture

statistic

S.D. Condition 1  (X°C/ Z% RH)Week 0
xxx.xx%

1

shelf life factor

Product Moisture

statistic

% RSD Condition 1  (X°C/ Z% RH)Week 0
xxx.x%

1

shelf life factor

Product Moisture

statistic

Average

Condition 2 (A °C/ B %RH)

Week 0


xxx.x%

10

shelf life factor

Product Moisture

statistic

S.D. Condition 2 (A °C/ B %RH)Week 0
xxx.xx%

10

shelf life factor

Product Moisture

statistic

% RSD Condition 2 (A °C/ B %RH)Week 0
xxx.x%

10

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