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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 Identifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = Tobacco Product Design Parameters (PD)

LB = Tobacco Product Testing (PT) - [Would Findings be better?]


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 (TT) 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

RowSTUDYIDDOMAINPTSEQPTREFIDSPTOBIDPTCASPTTESTCDPTTESTPTCATPTSCATPTTSTCNDPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT

1

VAP77777.111154-11-5NICNicotineSTABILITY STUDY
E-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
2TOB07PT2VAP77777.111154-11-5NICNicotineSTABILITY STUDY
E-Liquid Standard (Long Term) Condition




AEROSOL


1Week 01
3TOB07PT3VAP77777.1111494-97-3XXXXX

Nornicotine


STABILITY STUDYNicotine DegradantE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
4TOB07PT4VAP77777.1111494-52-0XXXXX

Anabasine


STABILITY STUDYNicotine DegradantE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
5TOB07PT5VAP77777.111156-81-5XXXXXGlycerinSTABILITY STUDYPrimary IngredientE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
6TOB07PT6VAP77777.111157-55-6XXXXXPropylene GlycolSTABILITY STUDYPrimary IngredientE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
7TOB07PT7VAP77777.111165-85-0XXXXXBenzoic AcidSTABILITY STUDYAcidE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
8TOB07PT8VAP77777.1111

89-78-1


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

XXXXXMentholSTABILITY STUDYFlavorantE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
9TOB07PT9VAP77777.1111
XXXXXVanillinSTABILITY STUDYFlavorantE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
10TOB07PT10VAP77777.111164091-91-4NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDYHPHCE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
11TOB07PT11VAP77777.111180508-23-2NNNN-nitrosonornicotineSTABILITY STUDYHPHCE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
12TOB07PT12VAP77777.111164091-91-4NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDYHPHCE-Liquid Standard (Long Term) Condition




AEROSOL


1Week 01
13TOB07PT13VAP77777.111180508-23-2NNNN-nitrosonornicotineSTABILITY STUDYHPHCE-Liquid Standard (Long Term) Condition




AEROSOL


1Week 01
14TOB07PT14VAP77777.1111
XXXXXMetals - NickelSTABILITY STUDYExtractables / Leachables E-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
15TOB07PT15VAP77777.1111
PHpHSTABILITY STUDY
E-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
16TOB07PT16VAP77777.1111
XXXXXEndotoxinSTABILITY STUDYToxinsE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
17TOB07PT17VAP77777.1111
XXXXXTAMCSTABILITY STUDYMicrobiologicalE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
18TOB07PT18VAP77777.1111
XXXXXTYMCSTABILITY STUDYMicrobiologicalE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
19TOB07PT19VAP77777.111175-07-0XXXXXAcetaldehydeSTABILITY STUDYAldehydeE-Liquid Standard (Long Term) Condition




E-LIQUID


1Week 01
20TOB07PT20VAP77777.1111
XXXXXAcetyl propionylSTABILITY STUDYDiketoneE-Liquid Standard (Long Term) Condition




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

DOMAINPTSEQPTREFIDPTGRPIDPTTESTCDPTTESTPTTSTCNDPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTREPNUMPTTPTPTTPTNUM
1TOB07PT211VAP77777.11NIC

Nicotine

E-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

1Week 01
2TOB07PT212VAP77777.11

NIC

NicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

2Week 01
3TOB07PT213VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

3Week 01
4TOB07PT214VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

1Week 244
5TOB07PT215VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

2Week 244
6TOB07PT216VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

3Week 244
7TOB07PT217VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

1Week 529
8TOB07PT218VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

2Week 529
9TOB07PT219VAP77777.11NICNicotineE-Liquid Standard (Long Term) Condition
mg/mL

mg/mLE-LIQUID

3Week 529
10TOB07PT220VAP77777.13NIC

Nicotine

E-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

1Week 01
11TOB07PT221VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

2Week 01
12TOB07PT222VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

3Week 01
13TOB07PT223VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

1Week 244
14TOB07PT224VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

2Week 244
15TOB07PT225VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

3Week 244
16TOB07PT226VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

1Week 529
17TOB07PT227VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

2Week 529
18TOB07PT228VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

3Week 529
19TOB07PT229VAP77777.13NICNicotineE-Vapor Standard Aerosol Condition
mg/puff

mg/puffAEROSOL

1Week 01
20TOB07PT230VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

2Week 01
21TOB07PT231VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

3Week 01
22TOB07PT232VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

1Week 244
23TOB07PT233VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

2Week 244
24TOB07PT234VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

3Week 244
25TOB07PT235VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

1Week 529
26TOB07PT236VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

2Week 529
27TOB07PT237VAP77777.14NICNicotineE-Vapor Intense Aerosol Condition
mg/puff

mg/puffAEROSOL

3Week 529
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.


The Trial Test Lookup (TL) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset. 

The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TLVAR1="PTTSTCND" and TLVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TLPARMCD/TLPAM. TLVAL and TVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above. 
(We've added TLVALU which was not originally part of the TL draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TLVALU) 

tl.xpt

tl.xpt

RowSTUDYIDDOMAINRDOMAINTLVAR1TLVRVAL1TLSEQTLGRPIDTLPARMCDTLPARMTLVALTLVALU
1

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition1
PUFFPROFPuff ProfileSQUARE
2

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition2


PUFFDUR

Puff Duration

1.25

sec

3

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition3


PUFFINT

Puff Interval

3

PUFF/min

4

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition4


PUFFBLCK

Puff Block

25

%

5

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition5
NUMPUFFTotal Number of Puffs

200

PUFF

6

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition6
PUFFVOLPuff Volume

10

mL

7

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition7
PUFFRNGPuff Range

100-200


8

TOB07

TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition81PUFFPAUSPuff Pause

60

s

9TOB07TLPTPTTSTCNDE-Liquid Standard (Long Term) Condition91PUFFPINTPuff Pause Interval

10

PUFF

$warningHtml


TO BE ARCHIVED; NOT FOR REVIEW. The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable. Values of PTTSTCND used in any PT dataset can be described in the TC dataset.

The example below shows the attributes of one testing regimen shown in the PT stability study above.

Rows 1-9:Show the attributes of the testing regimen identified in PTTSTCND="E-Vapor Standard Aerosol Condition". The value of this variable is taken directly from the value of PTTSTCND in the PT dataset from the stability study.
Rows 8-9:Show the puff pause duration and the puff pause interval. Taken together, these two records show that the regimen calls for a 60 second pause every 10 puffs.

tc.xpt

tc.xpt

Row

STUDYID

DOMAIN

PTTSTCND

TCSEQ

TCPARMCD

TCPARM

TCVAL

TCVALU

1

TOB07

TC

E-Vapor Standard Aerosol Condition

1

PUFFPROF

Puff Profile

SQUARE


2

TOB07

TC

E-Vapor Standard Aerosol Condition

2

PUFFDUR

Puff Duration 

1.25

sec

2

TOB07

TC

E-Vapor Standard Aerosol Condition

3

PUFFINT

Puff Interval

3

PUFF/min

4

TOB07

TC

E-Vapor Standard Aerosol Condition

4

PUFFBLCK

Puff Block

25

%

5

TOB07

TC

E-Vapor Standard Aerosol Condition

5

NUMPUFFTotal Number of Puffs

200

PUFF

6

TOB07

TC

E-Vapor Standard Aerosol Condition

6

PUFFVOLPuff Volume

10

mL

7

TOB07

TC

E-Vapor Standard Aerosol Condition

7

PUFFRNGPuff Range

100-200


8

TOB07

TC

E-Vapor Standard Aerosol Condition

8

PUFFPAUSPuff Pause

60

s

9

TOB07

TC

E-Vapor Standard Aerosol Condition

9

PUFFPINTPuff Pause Interval

10

PUFF

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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