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THIS EXAMPLE IS UNDER RE-CONSTRUCTION FOLLOWING THE TEAM CALL ON 17 JAN.  See also example in the "sandbox' here, which demonstrates the current approach reviewed on that call.

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.


The example shown below is not an all inclusive comprehensive example.  It is meant to be illustrative of the concepts.

Shelf life study has a protocol and provides the results of shelf life studies of Vapes 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 Vapes products for one testing condition at one timepoint and one replicate.

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

PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.

Rows 1-20:Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition.
Rows 2, 12, 13:Show the Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable.
Rows 17, 18:Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is E-Liquid Standard (Long Term) Condition.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT111
E-Liquid Standard (Long Term) Condition

1

VAP77777.154-11-5NICNicotineSTABILITY STUDY





E-LIQUID


1Week 01
2TOB07PT111
E-Liquid Standard (Long Term) Condition2VAP77777.154-11-5NICNicotineSTABILITY STUDY





AEROSOL


1Week 01
3TOB07PT111
E-Liquid Standard (Long Term) Condition3VAP77777.1494-97-3XXXXX

Nornicotine


STABILITY STUDYNicotine Degradant




E-LIQUID


1Week 01
4TOB07PT111
E-Liquid Standard (Long Term) Condition4VAP77777.1494-52-0XXXXX

Anabasine


STABILITY STUDYNicotine Degradant




E-LIQUID


1Week 01
5TOB07PT111
E-Liquid Standard (Long Term) Condition5VAP77777.156-81-5XXXXXGlycerinSTABILITY STUDYPrimary Ingredient




E-LIQUID


1Week 01
6TOB07PT111
E-Liquid Standard (Long Term) Condition6VAP77777.157-55-6XXXXXPropylene GlycolSTABILITY STUDYPrimary Ingredient




E-LIQUID


1Week 01
7TOB07PT111
E-Liquid Standard (Long Term) Condition7VAP77777.165-85-0XXXXXBenzoic AcidSTABILITY STUDYAcid




E-LIQUID


1Week 01
8TOB07PT111
E-Liquid Standard (Long Term) Condition8VAP77777.1

89-78-1


confirm this one, there are two - the other is 1490-04-6

XXXXXMentholSTABILITY STUDYFlavorant




E-LIQUID


1Week 01
9TOB07PT111
E-Liquid Standard (Long Term) Condition9VAP77777.1
XXXXXVanillinSTABILITY STUDYFlavorant




E-LIQUID


1Week 01
10TOB07PT111
E-Liquid Standard (Long Term) Condition10VAP77777.164091-91-4NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDYHPHC




E-LIQUID


1Week 01
11TOB07PT111
E-Liquid Standard (Long Term) Condition11VAP77777.180508-23-2NNNN-nitrosonornicotineSTABILITY STUDYHPHC




E-LIQUID


1Week 01
12TOB07PT111
E-Liquid Standard (Long Term) Condition12VAP77777.164091-91-4NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDYHPHC




AEROSOL


1Week 01
13TOB07PT111
E-Liquid Standard (Long Term) Condition13VAP77777.180508-23-2NNNN-nitrosonornicotineSTABILITY STUDYHPHC




AEROSOL


1Week 01
14TOB07PT111
E-Liquid Standard (Long Term) Condition14VAP77777.1
XXXXXMetals - NickelSTABILITY STUDYExtractables / Leachables 




E-LIQUID


1Week 01
15TOB07PT111
E-Liquid Standard (Long Term) Condition15VAP77777.1
PHpHSTABILITY STUDY





E-LIQUID


1Week 01
16TOB07PT111
E-Liquid Standard (Long Term) Condition16VAP77777.1
XXXXXEndotoxinSTABILITY STUDYToxins




E-LIQUID


1Week 01
17TOB07PT111
E-Liquid Standard (Long Term) Condition17VAP77777.1
XXXXXTAMCSTABILITY STUDYMicrobiological




E-LIQUID


1Week 01
18TOB07PT111
E-Liquid Standard (Long Term) Condition18VAP77777.1
XXXXXTYMCSTABILITY STUDYMicrobiological




E-LIQUID


1Week 01
19TOB07PT111
E-Liquid Standard (Long Term) Condition19VAP77777.175-07-0XXXXXAcetaldehydeSTABILITY STUDYAldehyde




E-LIQUID


1Week 01
20TOB07PT111
E-Liquid Standard (Long Term) Condition20VAP77777.1
XXXXXAcetyl propionylSTABILITY STUDYDiketone




E-LIQUID


1Week 01

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 Nicotine 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. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.

Rows 1-9:Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine 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 10-19:Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 20-27:Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.

pt.xpt

pt.xpt

Row

STUDYID

DOMAINSPTOBIDSTOCONIDPTSEQPTREFIDPTGRPIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTREPNUMPTTPTPTTPTNUM
1TOB07PT111E-Liquid Standard (Long Term) Condition211VAP77777.11NIC

Nicotine


mg/mL

mg/mLE-LIQUID

1Week 01
2TOB07PT111E-Liquid Standard (Long Term) Condition212VAP77777.11

NIC

Nicotine
mg/mL

mg/mLE-LIQUID

2Week 01
3TOB07PT111E-Liquid Standard (Long Term) Condition213VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

3Week 01
4TOB07PT111E-Liquid Standard (Long Term) Condition214VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

1Week 244
5TOB07PT111E-Liquid Standard (Long Term) Condition215VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

2Week 244
6TOB07PT111E-Liquid Standard (Long Term) Condition216VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

3Week 244
7TOB07PT111E-Liquid Standard (Long Term) Condition217VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

1Week 529
8TOB07PT111E-Liquid Standard (Long Term) Condition218VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

2Week 529
9TOB07PT111E-Liquid Standard (Long Term) Condition219VAP77777.11NICNicotine
mg/mL

mg/mLE-LIQUID

3Week 529
10TOB07PT111E-Vapor Standard Aerosol Condition220VAP77777.13NIC

Nicotine


mg/puff

mg/puffAEROSOL

1Week 01
11TOB07PT111E-Vapor Standard Aerosol Condition221VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

2Week 01
12TOB07PT111E-Vapor Standard Aerosol Condition222VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

3Week 01
13TOB07PT111E-Vapor Standard Aerosol Condition223VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

1Week 244
14TOB07PT111E-Vapor Standard Aerosol Condition224VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

2Week 244
15TOB07PT111E-Vapor Standard Aerosol Condition225VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

3Week 244
16TOB07PT111E-Vapor Standard Aerosol Condition226VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

1Week 529
17TOB07PT111E-Vapor Standard Aerosol Condition227VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

2Week 529
18TOB07PT111E-Vapor Standard Aerosol Condition228VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

3Week 529
19TOB07PT111E-Vapor Standard Aerosol Condition229VAP77777.13NICNicotine
mg/puff

mg/puffAEROSOL

1Week 01
20TOB07PT111E-Vapor Intense Aerosol Condition230VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

2Week 01
21TOB07PT
E-Vapor Intense Aerosol Condition231VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

3Week 01
22TOB07PT
E-Vapor Intense Aerosol Condition232VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

1Week 244
23TOB07PT
E-Vapor Intense Aerosol Condition233VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

2Week 244
24TOB07PT
E-Vapor Intense Aerosol Condition234VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

3Week 244
25TOB07PT
E-Vapor Intense Aerosol Condition235VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

1Week 529
26TOB07PT
E-Vapor Intense Aerosol Condition236VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

2Week 529
27TOB07PT
E-Vapor Intense Aerosol Condition237VAP77777.14NICNicotine
mg/puff

mg/puffAEROSOL

3Week 529
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Update the DI and DU. Check on the Aerosol Intense Condition.

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000
$warningHtml

du.xpt

du.xpt

Row

STUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1Medium Intensity Regimen
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5Medium Intensity Regimen
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6Medium Intensity Regimen
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7Medium Intensity Regimen
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8Medium Intensity Regimen1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9Medium Intensity Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

$warningHtml


es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESE-Liquid Standard (Long Term) Condition1HUMIDHumidity37%
2

TOB07

ESE-Liquid Standard (Long Term) Condition2TEMPTemperature24C
3

TOB07

ESE-Vapor Standard Aerosol Condition1HUMIDHumidity85%
4

TOB07

ESE-Vapor Standard Aerosol Condition2TEMPTemperature27C
5

TOB07

ESE-Vapor Intense Aerosol Condition1HUMIDHumidity95%
6

TOB07

ESE-Vapor Intense Aerosol Condition2TEMPTemperature31C
$warningHtml

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