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

Variable Name	Variable Label	Type	Core	CDISC Notes
STUDYID	Study Identifier	Char	Req	PT.STUDYID
USUBJID	Unique Subject Identifier	Char	Req	N/A
TRTP	Planned Treatment	Char	Cond	N/A
TRTA	Actual Treatment	Char	Cond	N/A
PARQUAL
PARAM	Parameter	Char	Req
PARAMCD	Parameter Code	text	Req
PARCAT1	Parameter Category 1	Char	Perm	PT.PTCAT
AVAL	Analysis Value	Num	Cond	see parameter level metadata
PTSEQ	Sequence Number	Num	Perm	PT.PTSEQ

ADPT

STUDYID	SPTOBID

PTSEQ

	PTREFID	PARQUAL	PARAM	PARAMCD	AVAL	PTTSTCND

PTORRES

PTSEQ

PTORRESU

TOB07

PTSTRESC

Smokeless01

PTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQ

	TOB77777.1	Product Moisture (%)	Average	AVERAGE		Condition 1 (X°C/ Z% RH)	1
TOB07	Smokeless01		TOB77777.1	Product Moisture (%)	S.D.	STD		Condition 1 (X°C/ Z% RH)	1
TOB07	Smokeless01		TOB77777.1	Product Moisture (%)	% RSD	PCTRSD		Condition 1 (X°C/ Z% RH)	1
TOB07	Smokeless01		TOB77777.1	pH	Average	AVERAGE

STABILITY STUDY

		Condition 1 (X°C/ Z% RH)	2
TOB07

%

Smokeless01

%

TOB77777.1

TOBACCO

pH	S.D.	STD		Condition 1 (X°C/ Z% RH)	2
TOB07	Smokeless01		TOB77777.1	pH	% RSD	PCTRSD	Condition 1 (X°C/ Z% RH)	2
TOB07	Smokeless01

		TOB77777.1	Water Activity	Average	AVERAGE		Condition 1 (X°C/ Z% RH)	3
TOB07	Smokeless01

2

TOB77777.1

pH

Water Activity

S.D.

STABILITY STUDY

pH

STD

Condition 1 (X°C/ Z% RH)

TOBACCO

3
TOB07	Smokeless01

3

TOB77777.1

Water Activity

% RSD

PCTRSD

STABILITY STUDY

Condition 1 (X°C/ Z% RH)

TOBACCO

3
TOB07	Smokeless01

4

TOB77777.1

4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH

Average

AVERAGE

Condition 1 (X°C/ Z% RH)

	4
TOB07	Smokeless01		TOB77777.1

NNK

4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g)

- FRESH

S.D.

STD

STABILITY STUDY

		Condition 1 (X°C/ Z% RH)	4
TOB07	Smokeless01		TOB77777.1	4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g

ng/gTOBACCO

) - FRESH

% RSD

PCTRSD

Condition 1 (X°C/ Z% RH)

4

FRESH


TOB07	Smokeless01

5

TOB77777.1

4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED

Average

AVERAGE

Condition 1 (X°C/ Z% RH)

	5
TOB07	Smokeless01		TOB77777.1

NNK

4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g)

- DRIED

S.D.

STD

STABILITY STUDY

		Condition 1 (X°C/ Z% RH)	5
TOB07	Smokeless01		TOB77777.1	4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g

ng/gTOBACCO

) - DRIED

% RSD

PCTRSD

Condition 1 (X°C/ Z% RH)

5

DRIED


TOB07	Smokeless01

6

TOB77777.1

N-nitrosonornicotine

NNN

) (ng/g) - FRESH	Average	AVERAGE		Condition 1 (X°C/ Z% RH)	6
TOB07	Smokeless01		TOB77777.1	N-nitrosonornicotine

STABILITY STUDY

) (ng/g) - FRESH	S.D.	STD		Condition 1 (X°C/ Z% RH)	6
TOB07	Smokeless01		TOB77777.1	N-nitrosonornicotine) (ng/g

ng/gTOBACCOFRESH

) - FRESH	% RSD	PCTRSD		Condition 1 (X°C/ Z% RH)	6
TOB07	Smokeless01

7

TOB77777.1

N-nitrosonornicotine

NNN

(ng/g) - DRIED	Average	AVERAGE		Condition 1 (X°C/ Z% RH)	7
TOB07	Smokeless01		TOB77777.1	N-nitrosonornicotine

STABILITY STUDY

(ng/g) - DRIED	S.D.	STD		Condition 1 (X°C/ Z% RH)	7
TOB07	Smokeless01		TOB77777.1	N-nitrosonornicotine (ng/g

ng/gTOBACCODRIED

) - DRIED	% RSD	PCTRSD		Condition 1 (X°C/ Z% RH)	7
TOB07	Smokeless01

8

TOB77777.1

Tobacco-specific nitrosamines

TSNA

(ng/g) - FRESH	Average	AVERAGE		Condition 1 (X°C/ Z% RH)	8
TOB07	Smokeless01		TOB77777.1	Tobacco-specific nitrosamines

STABILITY STUDY

(ng/g) - FRESH	S.D.	STD		Condition 1 (X°C/ Z% RH)	8
TOB07	Smokeless01		TOB77777.1	Tobacco-specific nitrosamines (ng/g

ng/gTOBACCO

) - FRESH

% RSD

PCTRSD

Condition 1 (X°C/ Z% RH)

8

FRESH


TOB07	Smokeless01

9

TOB77777.1

Tobacco-specific nitrosamines

TSNA

(ng/g) - DRIED	Average	AVERAGE		Condition 1 (X°C/ Z% RH)	9
TOB07	Smokeless01		TOB77777.1	Tobacco-specific nitrosamines

STABILITY STUDY

(ng/g) - DRIED	S.D.	STD		Condition 1 (X°C/ Z% RH)	9
TOB07	Smokeless01		TOB77777.1	Tobacco-specific nitrosamines (ng/g

ng/gTOBACCO

) - DRIED

% RSD

PCTRSD

Condition 1 (X°C/ Z% RH)

9

DRIED


TOB07	Smokeless01	TOB77777.1	Aerobic Plate Count	Average	AVERAGE	Condition 1 (X°C/ Z% RH)	10
TOB07	Smokeless01	TOB77777.1	Aerobic Plate Count

AEBPLCT

	S.D.	STD		Condition 1 (X°C/ Z% RH)	10
TOB07	Smokeless01		TOB77777.1	Aerobic Plate Count	% RSD

STABILITY STUDY

PCTRSD

Condition 1 (X°C/ Z% RH)

TOBACCO

10
TOB07	Smokeless01	TOB77777.1	Mold	Average	AVERAGE	Condition 1 (X°C/ Z% RH)	11
TOB07	Smokeless01	TOB77777.1	Mold

MOLDMold

	S.D.	STD		Condition 1 (X°C/ Z% RH)	11
TOB07	Smokeless01		TOB77777.1	Mold	% RSD	PCTRSD

STABILITY STUDY

Condition 1 (X°C/ Z% RH)

TOBACCO

11
TOB07	Smokeless01	TOB77777.1	Yeast	Average	AVERAGE	Condition 1 (X°C/ Z% RH)	12
TOB07	Smokeless01	TOB77777.1	Yeast

YEASTYeast

	S.D.	STD		Condition 1 (X°C/ Z% RH)	12
TOB07	Smokeless01		TOB77777.1	Yeast	% RSD	PCTRSD

STABILITY STUDY

Condition 1 (X°C/ Z% RH)

TOBACCO

12

param1	paramval1	param2	paramval2	colvar1	colvar2	colvaltyp	colval	colvalu	colord
shelf life factor	Product Moisture	statistic	Average	Condition 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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