You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 28 Next »

Tobacco product HPHC testing study results are represented in PT. These are just the data that show the testing results under specific storage conditions and smoking regimens. 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.
  • PTCAT represents the type of testing such as HPHC Testing or Design Parameter Testing
  • PTSCAT represents HPHC vs other constituents


https://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example.

This testing is conducted 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. 

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

This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset.

Rows 1-17:Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition is represented in STOCONID.
Rows 18-19:Shows the HPHC testing performed on one sample for two ingredients using the CANDIAN INTENSE test conditions. Row 18 Specimen is Smoke and Row 19 Specimen is Filler.

Row Captions Debug Message

Remember to keep number agreement between labels and captions.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTMETHODPTREPNUMPTTPTPTTPTNUMPTDTC
1TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition1
75-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC522µg/cigarette522522µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
2TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition2
107-02-8ACROLAcroleinHPHC TESTINGHPHC43µg/cigarette4343µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
3TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition3
107-13-1ACRLONIAcrylonitrileHPHC TESTINGHPHC7µg/cigarette77µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
4TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition4
92-67-1AMNPHEN44-AminobiphenylHPHC TESTINGHPHC1.2ng/cigarette1.21.2ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
5TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition5
134-32-7AMNPHTH11-AminonaphthaleneHPHC TESTINGHPHC14ng/cigarette1414ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
6TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition6
134-32-7AMNPHTH22-AminonaphthaleneHPHC TESTINGHPHC8ng/cigarette88ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
7TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition7
7664-41-7NH4AmmoniaHPHC TESTINGHPHC9µg/cigarette99µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
8TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition8
71-43-2BENZBenzeneHPHC TESTINGHPHC33µg/cigarette3333µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
9TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition9
50-32-8BENZAPBenzo[a]pyreneHPHC TESTINGHPHC6.8ng/cigarette6.86.8ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
10TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition10
630-08-0COCarbon monoxideHPHC TESTINGHPHC10.1mg/cigarette10.110.1mg/cigaretteSMOKEISO METHOD1Week 012022-09-30
11TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition11
4170-30-3CROTALDCrotonaldehydeHPHC TESTINGHPHC11µg/cigarette1111µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
12TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition12
50-00-0FORMALDFormaldehydeHPHC TESTINGHPHC27µg/cigarette2727µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
13TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition13
78-79-5ISOPRNIsopreneHPHC TESTINGHPHC320µg/cigarette320320µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
14TOB07PTCIG01aPUFFMASTER3KE-Liquid Standard (Long Term) Condition14Medium Intensity Regimen1954-11-05NICNicotineHPHC TESTINGHPHC0.721mg/cigarette0.7210.721mg/cigaretteSMOKEISO METHOD1Week 012022-09-30
15TOB07PTCIG01aPUFFMASTER3KE-Liquid Standard (Long Term) Condition15Medium Intensity Regimen64091-91-4NNK4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanoneHPHC TESTINGHPHC71ng/cigarette7171ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
16TOB07PTCIG01aPUFFMASTER3KE-Liquid Standard (Long Term) Condition16Medium Intensity Regimen16543-55-8NNNN-nitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
17TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition17
108-88-3
TolueneHPHC TESTINGHPHC53µg/cigarette5353µg/cigaretteSMOKEISO METHOD1Week 012022-09-30
18TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition18
75-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC1552µg/cigarette15521552µg/cigaretteSMOKECANADIAN INTENSE METHOD1Week 012022-09-30
19TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition19
7664-41-7AMMONIAAmmoniaHPHC TESTINGHPHC956µg/g956956µg/cigaretteFILLERCANADIAN INTENSE METHOD1Week 012022-09-30

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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).

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000
$warningHtml
Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).

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

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.

es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESE-Liquid Standard (Long Term) Condition1HUMIDHumidity38%
2

TOB07

ESE-Liquid Standard (Long Term) Condition2TEMPTemperature25C
$warningHtml

  • No labels