Shelf life study has a protocol and provides the results of shelf life studies of tobacco 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 smokeless tobacco products for one testing condition at one timepoint and one replicate. The second table has one analyte and two test conditions for many time points and replicates.
The Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.
Row 1:
Shows the PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in PTTSTCND which is Condition 1. Product Moisture is sometimes referred to as "Oven Volatiles".
Rows 4, 6, 8:
Show the NNK, NNN, and TSN tests with the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH".
Rows 5, 7, 9:
Show the NNK, NNN, and TSN tests with the tobacco product as "DRY WEIGHT BASIS" (DWB) using the PTSPCCND to show that the tobacco is "DRIED".
Rows 2-12:
Show the other analytes used in testing (pH, water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables.
*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.
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 moisture content using the TEST of Product Moisture (also known as Oven Volatile) percentage 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.
Rows 1-9:
Show the PTTEST of Product Moisture for Condition 1 which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for product moisture 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 10-18:
Show the PTTEST of Product Moisture for Condition 2 across the same timepoints shown for Condition 1. The PTGRPID is used to tie together a block of related records in a single domain.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
STOCONID
PTSEQ
PTREFID
PTTESTCD
PTTEST
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTSPCCND
PTMETHOD
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
Smokeless01
Condition 1
111
TOB77777.1
PRODMST
Product Moisture
51.93
%
51.93
51.93
%
TOBACCO
AS-IS
1
Week 0
1
2
TOB07
PT
Smokeless01
Condition 1
112
TOB77777.1
PRODMST
Product Moisture
51.96
%
51.96
51.96
%
TOBACCO
AS-IS
2
Week 0
1
3
TOB07
PT
Smokeless01
Condition 1
113
TOB77777.1
PRODMST
Product Moisture
51.98
%
51.98
51.98
%
TOBACCO
AS-IS
3
Week 0
1
4
TOB07
PT
Smokeless01
Condition 1
114
TOB77777.1
PRODMST
Product Moisture
51.75
%
51.75
51.75
%
TOBACCO
AS-IS
1
Week 8
4
5
TOB07
PT
Smokeless01
Condition 1
115
TOB77777.1
PRODMST
Product Moisture
51.75
%
51.75
51.75
%
TOBACCO
AS-IS
2
Week 8
4
6
TOB07
PT
Smokeless01
Condition 1
116
TOB77777.1
PRODMST
Product Moisture
51.67
%
51.67
51.67
%
TOBACCO
AS-IS
3
Week 8
4
7
TOB07
PT
Smokeless01
Condition 1
117
TOB77777.1
PRODMST
Product Moisture
52.05
%
52.05
52.05
%
TOBACCO
AS-IS
1
Week 48
9
8
TOB07
PT
Smokeless01
Condition 1
118
TOB77777.1
PRODMST
Product Moisture
52.68
%
52.68
52.68
%
TOBACCO
AS-IS
2
Week 48
9
9
TOB07
PT
Smokeless01
Condition 1
119
TOB77777.1
PRODMST
Product Moisture
52.21
%
52.21
52.21
%
TOBACCO
AS-IS
3
Week 48
9
10
TOB07
PT
Smokeless01
Condition 2
120
TOB77777.1
PRODMST
Product Moisture
51.93
%
51.93
51.93
%
TOBACCO
AS-IS
1
Week 0
1
11
TOB07
PT
Smokeless01
Condition 2
121
TOB77777.1
PRODMST
Product Moisture
51.96
%
51.96
51.96
%
TOBACCO
AS-IS
2
Week 0
1
12
TOB07
PT
Smokeless01
Condition 2
122
TOB77777.1
PRODMST
Product Moisture
51.98
%
51.98
51.98
%
TOBACCO
AS-IS
3
Week 0
1
13
TOB07
PT
Smokeless01
Condition 2
123
TOB77777.1
PRODMST
Product Moisture
51.80
%
51.80
51.80
%
TOBACCO
AS-IS
1
Week 8
4
14
TOB07
PT
Smokeless01
Condition 2
124
TOB77777.1
PRODMST
Product Moisture
51.77
%
51.77
51.77
%
TOBACCO
AS-IS
2
Week 8
4
15
TOB07
PT
Smokeless01
Condition 2
125
TOB77777.1
PRODMST
Product Moisture
51.84
%
51.84
51.84
%
TOBACCO
AS-IS
3
Week 8
4
16
TOB07
PT
Smokeless01
Condition 2
126
TOB77777.1
PRODMST
Product Moisture
52.18
%
52.18
52.18
%
TOBACCO
AS-IS
1
Week 48
9
17
TOB07
PT
Smokeless01
Condition 2
127
TOB77777.1
PRODMST
Product Moisture
52.21
%
52.21
52.21
%
TOBACCO
AS-IS
2
Week 48
9
18
TOB07
PT
Smokeless01
Condition 2
128
TOB77777.1
PRODMST
Product Moisture
51.87
%
51.87
51.87
%
TOBACCO
AS-IS
3
Week 48
9
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The storage conditions details of "E-Liquid Standard (Long Term) Condition 1" and "E-Liquid Standard (Long Term) Condition 1" are represented in the Environmental Storage Conditions (ES) dataset.
The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.