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NOTE: THIS SECTION MAY CHANGE . DEVICE DOMAIN MAY BE USED TO REPRESENT THE SMOKING MACHINE PARAMETERS 

Fix MATRIX variable 

Tobacco product stability study Tobacco product HPHC testing results are represented in the PT . These are just the data that show the testing results under specific storage conditions domain. This example illustrates HPHC testing and smoking regimens for a cigarette product. The details of the regimen and storage conditions are shown in separate datasets that follow this example.

  • The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
  • The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
  • The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
  • We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.

https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345 

The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product. example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See Section 3.1.4, Stability Studies, for more information and examples illustrating how to represent those data.

This example only shows test results for each constituent for one 1 replicate of 1 sample of one 1 product that was tested . The sampling plan (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor. In reality, sponsors would applicant or by regulatory requirement.  Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset . These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.          by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.

Note the use of the PTXFN (external file name) to indicate that the lab methodology was submitted as separate documentation.

ACETALD
Dataset wrap
Namept
Rowcaps
Rows 1-1517:

Show

the

HPHC testing performed

on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. 

in smoke produced by a smoking machine from the tobacco product identified in SPTOBID (CIG01a). Note of the use of SPDEVID as the device identifier for the smoking machine and the use of PTREFID to identify the smoking regimen (non-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke.

Row 18:Shows 1 analyte was tested with a different smoking regimen (PTREFID=INTENSE REGIMEN) using the same smoking machine.
Row 19:Shows 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null.Row 16:Shows the  HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. 
PTTPTNUM
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPEC
PTMETHOD
PTREPNUM
PTTPT
PTDTC
1TOB07PTCIG01aPUFFMASTER3K1
Sample 1
NON-INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC
1639
522ug/cigarette
1639
522
1639
522ug/cigarette
SMOKEISO INTENSE METHOD1Week 0
TL001_V5.pdfTPT LABCOSMOKE12022-09-30
2TOB07PTCIG01aPUFFMASTER3K2
Sample 1ACROL
NON-INTENSE REGIMENACROLEINAcroleinHPHC TESTINGHPHC
154
43ug/cigarette
154
43
154
43ug/cigarette
TL002_V3.6.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
3TOB07PTCIG01aPUFFMASTER3K3
Sample 1ACRLONI
NON-INTENSE REGIMENACRYNTRLAcrylonitrileHPHC TESTINGHPHC
7ug/cigarette77ug/cigaretteTL006_V6.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
4TOB07PTCIG01aPUFFMASTER3K4
Sample 1AMNPHEN4
NON-INTENSE REGIMENABP44-AminobiphenylHPHC TESTINGHPHC
1.2ng/cigarette1.21.2ng/cigaretteTL008_V3.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
5TOB07PTCIG01aPUFFMASTER3K5
Sample 1
NON-INTENSE REGIMENAMNPHTH11-AminonaphthaleneHPHC TESTINGHPHC
ISO INTENSE METHOD
14ng/cigarette1414ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE12022-09-30
6TOB07PTCIG01aPUFFMASTER3K6
Sample 1NH4
NON-INTENSE REGIMENAMNPHTH22-Aminonaphthalene
Ammonia
HPHC TESTINGHPHC
29.2
8
ug
ng/cigarette
29.229.2ug/cigarette
88ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
7TOB07PTCIG01aPUFFMASTER3K7
Sample 1BENZ
NON-INTENSE REGIMENAMMONIAAmmonia
Benzene
HPHC TESTINGHPHC
9ug/cigarette99ug/cigaretteTL020_V4.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
8TOB07PTCIG01aPUFFMASTER3K8
Sample 1BENZAP
NON-INTENSE REGIMENBENZENEBenzene
Benzo[a]pyrene
HPHC TESTINGHPHC
30.5
33ug/cigarette
30.5
3333
30.5
ug/cigarette
ISO INTENSE METHOD
TL017_V1.1.pdfTPT LABCOSMOKE12022-09-30
9TOB07PTCIG01aPUFFMASTER3K9
Sample 1CO
NON-INTENSE REGIMENBZAPYRBenzo[a]pyrene
Carbon monoxide
HPHC TESTINGHPHC
28
6.
2
8
ug
ng/cigarette
28
6.
2
8
28
6.
2
8
ug
ng/cigarette
ISO INTENSE METHOD
TL017_V1.1.pdfTPT LABCOSMOKE12022-09-30
10TOB07PTCIG01aPUFFMASTER3K10
Sample 1CROTALD
NON-INTENSE REGIMENCMONOXCarbon Monoxide
Crotonaldehyde
HPHC TESTINGHPHC
0.010.010.01
10.1mg/cigarette10.110.1mg/cigaretteTL019_V3.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
11TOB07PTCIG01aPUFFMASTER3K11
Sample 1FORMALD
NON-INTENSE REGIMENCROTNALDCrotonaldehyde
Formaldehyde
HPHC TESTINGHPHC
83.2
11ug/cigarette
83.2
1111
83.2
ug/cigarette
ISO INTENSE METHOD
TL001_V5.pdfTPT LABCOSMOKE12022-09-30
12TOB07PTCIG01aPUFFMASTER3K12
Sample 1ISOPRN
NON-INTENSE REGIMENFORMALDFormaldehyde
Isoprene
HPHC TESTINGHPHC
27ug/cigarette2727ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
13TOB07PTCIG01aPUFFMASTER3K13
Sample 1NIC
NON-INTENSE REGIMENISOPRENEIsoprene
Nicotine
HPHC TESTINGHPHC
1.71
320ug/cigarette
1.71
320320
1.71
ug/cigarette
TL041_V1.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
14TOB07PTCIG01aPUFFMASTER3K14
Sample 1
NON-INTENSE REGIMENNICOTINE
NNK
Nicotine
-derived Nitrosamine Ketone
HPHC TESTINGHPHC
0.721mg/cigarette0.7210.721mg/cigaretteTL007_V2.1.pdfTPT LABCOSMOKE
ISO INTENSE METHOD
12022-09-30
15TOB07PTCIG01aPUFFMASTER3K15
Sample 1NNN
NON-INTENSE REGIMENNNKNicotine-Derived Nitrosamine Ketone
N-nitrosonornicotine
HPHC TESTINGHPHC
284
71
ug
ng/cigarette
284
71
284
71
ug
ng/cigarette
ISO INTENSE METHOD
TL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
16TOB07PTCIG01aPUFFMASTER3K16
Sample 1ACETALD
NON-INTENSE REGIMENNNNN-Nitrosonornicotine
Acetaldehyde
HPHC TESTINGHPHC
1569
85
ug
ng/cigarette
1569
85
1569
85
ug
ng/cigarette
CANADIAN INTENSE METHOD
TL026_V12.2.pdfTPT LABCOSMOKE12022-09-30

The Environmental Storage Conditions (ES) dataset can be used to provide additional details on any test conditions or methods used to perform the testing.   

...

NameES

...

TOB07

...

TOB07

...

TOB07

...

17TOB07PTCIG01aPUFFMASTER3K17NON-INTENSE REGIMENTOLUENETolueneHPHC TESTINGHPHC53ug/cigarette5353ug/cigaretteTL011_V3.3.pdfTPT LABCOSMOKE12022-09-30
18TOB07PTCIG01aPUFFMASTER3K18INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC1552ug/cigarette15521552ug/cigaretteTL009_V4.3.pdfTPT LABCOSMOKE12022-09-30
19TOB07PTCIG01a
19
AMMONIAAmmoniaHPHC TESTINGHPHC956ug/g956956ug/cigaretteTL016_V1.2.pdfTPT LABCOTOBACCO FILLER12022-09-30

The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the applicant-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.

...

TOB07

...

TOB07

...

Next ,we use DU (device-in use properties/settings) for smoking regimen. Note that the separate DI (device identifiers) dataset is needed to show identifying parameters of the "PUFFMASTER3K" smoking machine. We cannot have DU without also including DI).

Dataset wrap
titlelb.xpt
Namedi
Dataset2
RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000

Details of the smoking regimen performed by the smoking machine are represented as device in-use properties , (such as settings) of the smoking machine. They are linked to the stability data HPHC testing results in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).

Dataset wrap
Namedu
Rowcaps
Rows 1-9:Show the parameters of the non-intense smoking regimen.
Rows 8-9:Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this smoking regimen pauses for 60 seconds every 10 puffs.
Rows 10-18:Show the parameters of the intense smoking regimen.
Rows 17-18:Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this smoking regimen pauses for 30 seconds every 10 puffs.
Dataset2

Row

STUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1Medium Intensity RegimenNON-INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2Medium Intensity RegimenNON-INTENSE REGIMEN

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3Medium Intensity RegimenNON-INTENSE REGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4Medium Intensity RegimenNON-INTENSE REGIMEN

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5Medium Intensity RegimenNUMPUFFNON-INTENSE REGIMEN

PUFFNUM

Total Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6Medium Intensity RegimenNON-INTENSE REGIMEN
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7Medium Intensity RegimenNON-INTENSE REGIMEN
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8Medium Intensity RegimenNON-INTENSE REGIMEN1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9Medium Intensity RegimenNON-INTENSE REGIMEN1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

Finally, we assume we still need to parse out storage conditions of "E-Liquid Standard (Long Term) Condition". Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset.

  • The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
  • These values were made up, but we assume they'd look something like this.
10

TOB07

DUPUFFMASTER3K1INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

11

TOB07

DUPUFFMASTER3K2INTENSE REGIMEN

PUFFDUR

Puff Duration

2.25

sec

2.25

2.25

sec

12

TOB07

DUPUFFMASTER3K3INTENSE REGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

13

TOB07

DUPUFFMASTER3K4INTENSE REGIMEN

PUFFBLCK

Puff Block

30

%

30

30

%

14

TOB07

DUPUFFMASTER3K5INTENSE REGIMEN
PUFFNUMNumber of Puffs

100

PUFF

100

100

PUFF

15

TOB07

DUPUFFMASTER3K6INTENSE REGIMEN
PUFFVOLPuff Volume

20

mL

20

20

mL

16

TOB07

DUPUFFMASTER3K7INTENSE REGIMEN
PUFFRNGPuff Range

50-150


50-150



17

TOB07

DUPUFFMASTER3K8INTENSE REGIMEN2PUFFPAUSPuff Pause

30

s

30

30

s

18TOB07DUPUFFMASTER3K9INTENSE REGIMEN2PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

Dataset wrap
Namees
C
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESE-Liquid Standard (Long Term) Condition1HUMIDHumidity38%
2

TOB07

ESE-Liquid Standard (Long Term) Condition2TEMPTemperature25