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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.


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.


Row 1:Shows the LBTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in LBTSTCND which is Condition 1 (X°C/ Z% RH). Product Moisture is sometimes referred to as "Oven Volatiles".
Rows 4, 6, 8Shows the NNK, NNN, and TSN tests with the tobacco product "as-is" using the LBSPCCND to show that the tobacco is "FRESH".
Rows 5, 7, 9Shows the NNK, NNN, and TSN tests with the tobacco product as "Dry weight basis (DWB)" using the LBSPCCND 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 LBTEST and LBTESTCD variables.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

lb.xpt

lb.xpt

RowSTUDYIDDOMAINLBSEQLBREFIDLBTESTCDLBTESTLBTSTCNDLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBSPECLBSPCCNDLBMETHODLBLLOQLBREPNUMLBTPTLBTPTNUM
1TOB07LB1TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCO


1Week 01
2TOB07LB2TOB77777.1PHpHCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
3TOB07LB3TOB77777.1H2OACTWater ActivityCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
4TOB07LB4TOB77777.1NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)Condition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCOFRESH

1Week 01
5TOB07LB5TOB77777.1NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)Condition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCODRIED

1Week 01
6TOB07LB6TOB77777.1NNNN-nitrosonornicotineCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCOFRESH

1Week 01
7TOB07LB7TOB77777.1NNNN-nitrosonornicotineCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCODRIED

1Week 01
8TOB07LB8TOB77777.1TSNATobacco-specific nitrosaminesCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCOFRESH

1Week 01
9TOB07LB9TOB77777.1TSNATobacco-specific nitrosaminesCondition 1 (X°C/ Z% RH)
ng/g

ng/gTOBACCODRIED

1Week 01
10TOB07LB10TOB77777.1AEBPLCTAerobic Plate CountCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
11TOB07LB11TOB77777.1MOLDMoldCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01
12TOB07LB12TOB77777.1YEASTYeastCondition 1 (X°C/ Z% RH)




TOBACCO


1Week 01

Dataset Debug Message

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Dataset Wrapper Debug Message

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

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

lb.xpt

lb.xpt

RowSTUDYIDDOMAINLBSEQLBREFIDLBTESTCDLBTESTLBTSTCNDLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBSPECLBSPCCNDLBMETHODLBREPNUMLBTPTLBTPTNUM
1TOB07LB111TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
1Week 01
2TOB07LB112TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
2Week 01
3TOB07LB113TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
3Week 01
4TOB07LB114TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
1Week 84
5TOB07LB115TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
2Week 84
6TOB07LB116TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
3Week 84
7TOB07LB117TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
1Week 489
8TOB07LB118TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
2Week 489
9TOB07LB119TOB77777.1PRODMSTProduct MoistureCondition 1 (X°C/ Z% RH)
%

%TOBACCOFRESH
3Week 489
10TOB07LB120TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
1Week 01
11TOB07LB121TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
2Week 01
12TOB07LB122TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
3Week 01
13TOB07LB123TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
1Week 84
14TOB07LB124TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
2Week 84
15TOB07LB125TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
3Week 84
16TOB07LB126TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
1Week 489
17TOB07LB127TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
2Week 489
18TOB07LB128TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)
%

%TOBACCOFRESH
3Week 489
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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