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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.


Dataset Wrapper Debug Message

Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.

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, 8Shows 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, 9Shows 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.

Row Captions 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 portions of the content using the TEST of Potential Combustion Products and Microbial 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 Potential Combusion Products for E-Liquid Standard (Long Term) Condition which is shown in TTTSTCND. The sample of various timepoints that may be used in the testing for Potential Combusion Products 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 Potential Combusion Products for E-Liquid Accelerated Aging Condition across the same timepoints. The TTGRPID is used to tie together a block of related records in a single domain.
Rows 19-28:Show the TTTEST of MIcrobiological for E-Vapor Standard Aerosol Condition across the same timepoints. The TTGRPID is used to tie together a block of related records in a single domain.
Rows 29-36:Show the TTTEST of MIcrobiological for E-Vapor Intense Aerosol Condition across the same timepoints. The TTGRPID is used to tie together a block of related records in a single domain.

tt.xpt

tt.xpt

RowSTUDYIDDOMAINTTSEQTTREFIDTTTESTCDTTTESTTTTSTCNDTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESUTTSPECTTSPCCNDTTMETHODTTREPNUMTTTPTTTTPTNUM
1TOB07TT211VAP77777.1XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

1Week 01
2TOB07TT212VAP77777.2XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

2Week 01
3TOB07TT213VAP77777.3XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

3Week 01
4TOB07TT214VAP77777.4XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

1Week 84
5TOB07TT215VAP77777.5XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

2Week 84
6TOB07TT216VAP77777.6XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

3Week 84
7TOB07TT217VAP77777.7XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

1Week 489
8TOB07TT218VAP77777.8XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

2Week 489
9TOB07TT219VAP77777.9XXXXXPotential Combustion ProductsE-Liquid Standard (Long Term) Condition
%

%E-LIQUID

3Week 489
10TOB07TT220VAP77777.10YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

1Week 01
11TOB07TT221VAP77777.11YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

2Week 01
12TOB07TT222VAP77777.12YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

3Week 01
13TOB07TT223VAP77777.13YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

1Week 84
14TOB07TT224VAP77777.14YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

2Week 84
15TOB07TT225VAP77777.15YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

3Week 84
16TOB07TT226VAP77777.16YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

1Week 489
17TOB07TT227VAP77777.17YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

2Week 489
18TOB07TT228VAP77777.18YYYYYYPotential Combustion ProductsE-Liquid Accelerated Aging Condition
%

%E-LIQUID

3Week 489
19TOB07TT229VAP77777.1AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

1Week 01
20TOB07TT230VAP77777.2AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

2Week 01
21TOB07TT231VAP77777.3AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

3Week 01
22TOB07TT232VAP77777.4AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

1Week 84
23TOB07TT233VAP77777.5AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

2Week 84
24TOB07TT234VAP77777.6AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

3Week 84
25TOB07TT235VAP77777.7AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

1Week 489
26TOB07TT236VAP77777.8AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

2Week 489
27TOB07TT237VAP77777.9AAAAAMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

3Week 489
28TOB07TT238VAP77777.10BBBBBBMicrobiologicalE-Vapor Standard Aerosol Condition
%

%E-LIQUID

1Week 01
29TOB07TT239VAP77777.11BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

2Week 01
30TOB07TT240VAP77777.12BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

3Week 01
31TOB07TT241VAP77777.13BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

1Week 84
32TOB07TT242VAP77777.14BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

2Week 84
33TOB07TT243VAP77777.15BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

3Week 84
34TOB07TT244VAP77777.16BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

1Week 489
35TOB07TT245VAP77777.17BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

2Week 489
36TOB07TT246VAP77777.18BBBBBBMicrobiologicalE-Vapor Intense Aerosol Condition
%

%E-LIQUID

3Week 489
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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