Page History

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-155

Tobacco product HPHC testing results are represented in the PT domain. This example illustrates HPHC testing and smoking regimens for a cigarette product. The example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See the Section 3.1.4, Stability Studies section, 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 one 1 sample of one 1 product that was tested (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 applicant or by regulatory requirement.  Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.

...

Dataset wrap
Name pt
Rowcaps Rows 1-17: Show HPHC testing performed 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 (Nonnon-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-189 Row 18: Shows one 1 analyte was tested with a different smoking regimen (PTREFID=INTENSE REGIMEN) using the same smoking machine. Row 19: Shows one 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null. Dataset2 Row STUDYID DOMAIN SPTOBID SPDEVID PTSEQ PTREFID PTTESTCD PTTEST PTCAT PTSCAT PTORRES PTORRESU PTSTRESC PTSTRESN PTSTRESU PTXFN PTNAM PTSPEC PTREPNUM PTDTC 1 TOB07 PT CIG01a PUFFMASTER3K 1 NON-INTENSE REGIMEN ACTALD Acetaldehyde HPHC TESTING HPHC 522 ug/cigarette 522 522 ug/cigarette TL001_V5.pdf TPT LABCO SMOKE 1 2022-09-30 2 TOB07 PT CIG01a PUFFMASTER3K 2 NON-INTENSE REGIMEN ACROLEIN Acrolein HPHC TESTING HPHC 43 ug/cigarette 43 43 ug/cigarette TL002_V3.6.pdf TPT LABCO SMOKE 1 2022-09-30 3 TOB07 PT CIG01a PUFFMASTER3K 3 NON-INTENSE REGIMEN ACRYNTRL Acrylonitrile HPHC TESTING HPHC 7 ug/cigarette 7 7 ug/cigarette TL006_V6.pdf TPT LABCO SMOKE 1 2022-09-30 4 TOB07 PT CIG01a PUFFMASTER3K 4 NON-INTENSE REGIMEN ABP4 4-Aminobiphenyl HPHC TESTING HPHC 1.2 ng/cigarette 1.2 1.2 ng/cigarette TL008_V3.pdf TPT LABCO SMOKE 1 2022-09-30 5 TOB07 PT CIG01a PUFFMASTER3K 5 NON-INTENSE REGIMEN AMNPHTH1 1-Aminonaphthalene HPHC TESTING HPHC 14 ng/cigarette 14 14 ng/cigarette TL003_V1.4.pdf TPT LABCO SMOKE 1 2022-09-30 6 TOB07 PT CIG01a PUFFMASTER3K 6 NON-INTENSE REGIMEN AMNPHTH2 2-Aminonaphthalene HPHC TESTING HPHC 8 ng/cigarette 8 8 ng/cigarette TL003_V1.4.pdf TPT LABCO SMOKE 1 2022-09-30 7 TOB07 PT CIG01a PUFFMASTER3K 7 NON-INTENSE REGIMEN AMMONIA Ammonia HPHC TESTING HPHC 9 ug/cigarette 9 9 ug/cigarette TL020_V4.pdf TPT LABCO SMOKE 1 2022-09-30 8 TOB07 PT CIG01a PUFFMASTER3K 8 NON-INTENSE REGIMEN BENZENE Benzene HPHC TESTING HPHC 33 ug/cigarette 33 33 ug/cigarette TL017_V1.1.pdf TPT LABCO SMOKE 1 2022-09-30 9 TOB07 PT CIG01a PUFFMASTER3K 9 NON-INTENSE REGIMEN BZAPYR Benzo[a]pyrene HPHC TESTING HPHC 6.8 ng/cigarette 6.8 6.8 ng/cigarette TL017_V1.1.pdf TPT LABCO SMOKE 1 2022-09-30 10 TOB07 PT CIG01a PUFFMASTER3K 10 NON-INTENSE REGIMEN CMONOX Carbon Monoxide HPHC TESTING HPHC 10.1 mg/cigarette 10.1 10.1 mg/cigarette TL019_V3.pdf TPT LABCO SMOKE 1 2022-09-30 11 TOB07 PT CIG01a PUFFMASTER3K 11 NON-INTENSE REGIMEN CROTNALD Crotonaldehyde HPHC TESTING HPHC 11 ug/cigarette 11 11 ug/cigarette TL001_V5.pdf TPT LABCO SMOKE 1 2022-09-30 12 TOB07 PT CIG01a PUFFMASTER3K 12 NON-INTENSE REGIMEN FORMALD Formaldehyde HPHC TESTING HPHC 27 ug/cigarette 27 27 ug/cigarette TL001_V5.pdf TPT LABCO SMOKE 1 2022-09-30 13 TOB07 PT CIG01a PUFFMASTER3K 13 NON-INTENSE REGIMEN ISOPRENE Isoprene HPHC TESTING HPHC 320 ug/cigarette 320 320 ug/cigarette TL041_V1.pdf TPT LABCO SMOKE 1 2022-09-30 14 TOB07 PT CIG01a PUFFMASTER3K 14 NON-INTENSE REGIMEN NICOTINE Nicotine HPHC TESTING HPHC 0.721 mg/cigarette 0.721 0.721 mg/cigarette TL007_V2.1.pdf TPT LABCO SMOKE 1 2022-09-30 15 TOB07 PT CIG01a PUFFMASTER3K 15 NON-INTENSE REGIMEN NNK Nicotine-Derived Nitrosamine Ketone HPHC TESTING HPHC 71 ng/cigarette 71 71 ng/cigarette TL026_V12.2.pdf TPT LABCO SMOKE 1 2022-09-30 16 TOB07 PT CIG01a PUFFMASTER3K 16 NON-INTENSE REGIMEN NNN N-Nitrosonornicotine HPHC TESTING HPHC 85 ng/cigarette 85 85 ng/cigarette TL026_V12.2.pdf TPT LABCO SMOKE 1 2022-09-30 17 TOB07 PT CIG01a PUFFMASTER3K 17 NON-INTENSE REGIMEN TOLUENE Toluene HPHC TESTING HPHC 53 ug/cigarette 53 53 ug/cigarette TL011_V3.3.pdf TPT LABCO SMOKE 1 2022-09-30 18 TOB07 PT CIG01a PUFFMASTER3K 18 INTENSE REGIMEN ACTALD Acetaldehyde HPHC TESTING HPHC 1552 ug/cigarette 1552 1552 ug/cigarette TL009_V4.3.pdf TPT LABCO SMOKE 1 2022-09-30 19 TOB07 PT CIG01a 19 AMMONIA Ammonia HPHC TESTING HPHC 956 ug/g 956 956 ug/cigarette TL016_V1.2.pdf TPT LABCO TOBACCO FILLER 1 2022-09-30

...

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 HPHC testing results in PT above by matching values of PTREFID/DUREFID.

Dataset wrap
Name du
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 tell us 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 tell us indicate that this smoking regimen pauses for 30 seconds every 10 puffs. Dataset2 Row STUDYID DOMAIN SPDEVID DUSEQ DUREFID DUGRPID DUTESTCD DUTEST DUORRES DUORRESU DUSTRESC DUSTRESN DUSTRESU 1 TOB07 DU PUFFMASTER3K 1 NON-INTENSE REGIMEN PUFFPROF Puff Profile SQUARE SQUARE 2 TOB07 DU PUFFMASTER3K 2 NON-INTENSE REGIMEN PUFFDUR Puff Duration 1.25 sec 1.25 1.25 sec 3 TOB07 DU PUFFMASTER3K 3 NON-INTENSE REGIMEN PUFFINT Puff Interval 3 PUFF/min 3 3 PUFF/min 4 TOB07 DU PUFFMASTER3K 4 NON-INTENSE REGIMEN PUFFBLCK Puff Block 25 % 25 25 % 5 TOB07 DU PUFFMASTER3K 5 NON-INTENSE REGIMEN NUMPUFF PUFFNUM Total Number of Puffs 200 PUFF 200 200 PUFF 6 TOB07 DU PUFFMASTER3K 6 NON-INTENSE REGIMEN PUFFVOL Puff Volume 10 mL 10 10 mL 7 TOB07 DU PUFFMASTER3K 7 NON-INTENSE REGIMEN PUFFRNG Puff Range 100-200 100-200 8 TOB07 DU PUFFMASTER3K 8 NON-INTENSE REGIMEN 1 PUFFPAUS Puff Pause 60 s 60 60 s 9 TOB07 DU PUFFMASTER3K 9 NON-INTENSE REGIMEN 1 PUFFPINT Puff Pause Interval 10 PUFF 10 10 PUFF 10 TOB07 DU PUFFMASTER3K 1 INTENSE REGIMEN PUFFPROF Puff Profile SQUARE SQUARE 11 TOB07 DU PUFFMASTER3K 2 INTENSE REGIMEN PUFFDUR Puff Duration 2.25 sec 2.25 2.25 sec 12 TOB07 DU PUFFMASTER3K 3 INTENSE REGIMEN PUFFINT Puff Interval 3 PUFF/min 3 3 PUFF/min 13 TOB07 DU PUFFMASTER3K 4 INTENSE REGIMEN PUFFBLCK Puff Block 30 % 30 30 % 14 TOB07 DU PUFFMASTER3K 5 INTENSE REGIMEN NUMPUFFPUFFNUM Total Number of Puffs 100 PUFF 100 100 PUFF 15 TOB07 DU PUFFMASTER3K 6 INTENSE REGIMEN PUFFVOL Puff Volume 20 mL 20 20 mL 16 TOB07 DU PUFFMASTER3K 7 INTENSE REGIMEN PUFFRNG Puff Range 50-150 50-150 17 TOB07 DU PUFFMASTER3K 8 INTENSE REGIMEN 2 PUFFPAUS Puff Pause Pause 30 s 30 30 s 18 TOB07 DU PUFFMASTER3K 9 INTENSE REGIMEN 2 PUFFPINT Puff Pause Interval 10 PUFF 10 10 PUFF