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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.

Tobacco domains

DI = TO for Tobacco Product Identifier

SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier

DO/DU = Tobacco Design Parameters (DP)

LB = Tobacco Product Testing (TT)


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 tobacco products for one testing condition at one timepoint and one replicate.


Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.


Row 1:Shows the TTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in TTTSTCND which is Condition 1 (X°C/ Z% RH). 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 TTSPCCND 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 TTSPCCND 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 TTTEST and TTTESTCD variables.

tt.xpt

tt.xpt

RowSTUDYIDDOMAINTTSEQTTREFIDSPTOBIDTTTESTCDTTTESTTTCATTTTSTCNDTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESUTTSPECTTSPCCNDTTMETHODTTLLOQTTREPNUMTTTPTTTTPTNUM
1TOB07TT1TOB77777.1Cig01aPRODMSTProduct MoistureSTABILITY STUDYCondition 1 (X°C/ Z% RH)
%

%TOBACCO


1Week 01
2TOB07TT2TOB77777.1Cig01aPHpHSTABILITY STUDYCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
3TOB07TT3TOB77777.1Cig01aH2OACTWater ActivitySTABILITY STUDYCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
4TOB07TT4TOB77777.1Cig01aNNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDYCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCOFRESH

1Week 01
5TOB07TT5TOB77777.1Cig01aNNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDYCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCODRIED

1Week 01
6TOB07TT6TOB77777.1Cig01aNNNN-nitrosonornicotineSTABILITY STUDYCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCOFRESH

1Week 01
7TOB07TT7TOB77777.1Cig01aNNNN-nitrosonornicotineSTABILITY STUDYCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCODRIED

1Week 01
8TOB07TT8TOB77777.1Cig01aTSNATobacco-specific nitrosaminesSTABILITY STUDYCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCOFRESH

1Week 01
9TOB07TT9TOB77777.1Cig01aTSNATobacco-specific nitrosaminesSTABILITY STUDYCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCODRIED

1Week 01
10TOB07TT10TOB77777.1Cig01aAEBPLCTAerobic Plate CountSTABILITY STUDYCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
11TOB07TT11TOB77777.1Cig01aMOLDMoldSTABILITY STUDYCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
12TOB07TT12TOB77777.1Cig01aYEASTYeastSTABILITY STUDYCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

*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 TTTPTNUM of 2,3, etc. are not shown for visual viewing purposes.

Rows 1-9:Show the TTTEST of Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in TTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in TTTPT. The TTTPTNUM 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 TTTEST of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1. The TTGRPID is used to tie together a block of related records in a single domain.

tt.xpt

tt.xpt

RowSTUDYIDDOMAINTTSEQTTREFIDTTTESTCDTTTESTTTTSTCNDTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESUTTSPECTTSPCCNDTTMETHODTTREPNUMTTTPTTTTPTNUM
1TOB07TT111TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

1Week 01
2TOB07TT112TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

2Week 01
3TOB07TT113TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

3Week 01
4TOB07TT114TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

1Week 84
5TOB07TT115TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

2Week 84
6TOB07TT116TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

3Week 84
7TOB07TT117TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

1Week 489
8TOB07TT118TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

2Week 489
9TOB07TT119TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO

3Week 489
10TOB07TT120TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

1Week 01
11TOB07TT121TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

2Week 01
12TOB07TT122TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

3Week 01
13TOB07TT123TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

1Week 84
14TOB07TT124TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

2Week 84
15TOB07TT125TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

3Week 84
16TOB07TT126TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

1Week 489
17TOB07TT127TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

2Week 489
18TOB07TT128TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCO

3Week 489
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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