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Rows 1-27: | Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable. | Rows 7-18: | Show the design parameter specification for portioned characteristics. |
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU |
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1 | | PD | SNUS-77 | | TOCUTSIZ | Tobacco Cut Size | | | | | 2 | | PD | SNUS-77 | | TOPRTSIZ | or Tobacco Particle Size | | | | | 23 | TOB17 | PD | SNUS-77 | 2 | TOMOISTR | Tobacco Moisture | 32.2 | 31 | 34 | % | 34 | TOB17 | PD | SNUS-77 | 3 | PRTLENG | Portion Length | 38 | 36.5 | 39.5 | mm | 45 | TOB17 | PD | SNUS-77 | 4 | PRTWDTH | Portion Width | 16 | 15 | 17 | mm | 56 | TOB17 | PD | SNUS-77 | 5 | PRTMASS | Portion Mass | 1000 | 900 | 1100 | mg | 67 | TOB17 | PD | SNUS-77 | 6 | PRTTHICK | Portion (pouch) material thickness (if applicable) | 0.06 | 0.055 | 0.065 | mm | 78 | TOB17 | PD | SNUS-77 | 7 | PRTMWGT | Pouch material basis weight (if applicable) | 16 | 15 | 17 | g/m^2 | 89 | TOB17 | PD | SNUS-77 | 8 | PRTMPOR | Pouch material porosity (permeability) (if applicable) | 1850 | 1600 | 2200 | L/m^2/s | 910 | TOB17 | PD | SNUS-77 | 9 | NICTDSRT | Nicotine dissolution rate | 15 | 5 | 22 | %/min |
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The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset).
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Rows 1-6: | Show the tobacco design parameter specification test and the result in ORRES for the SNUS. (needs populated).
| Row 3: | Shows the design parameter specification for the portion mass.
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTTSTCND | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB17 | PT | SNUS-77 | 1 |
| TOCUTSIZ | Tobacco Cut Size |
| DESIGN PARAMETER TESTING |
| | cuts per inch | | | mm or cuts per inch | 1 | Week 0 | 1 | 2 | TOB17 | PT | SNUS-77 | 1 |
| TOPRTSIZ | Tobacco Particle Size |
| DESIGN PARAMETER TESTING |
| | mm or cuts per inch | | | mm or cuts per inch | 1 | Week 0 | 1 | 23 | TOB17 | PT | SNUS-77 | 2 |
| TOMOISTR | Tobacco Moisture |
| DESIGN PARAMETER TESTING |
| 31.8 | % | 31.8 | 31.8 | % | 1 | Week 0 | 1 | 34 | TOB17 | PT | SNUS-77 | 3 |
| PRTMASS | Portion Mass |
| DESIGN PARAMETER TESTING |
| 998 | mg | 998 | 998 | mg | 1 | Week 0 | 1 | 45 | TOB17 | PT | SNUS-77 | 4 |
| PRTMWGT | Pouch material basis weight |
| DESIGN PARAMETER TESTING |
| 15.3 | g/m^2 | 15.3 | 15.3 | g/m^2 | 1 | Week 0 | 1 | 56 | TOB17 | PT | SNUS-77 | 5 |
| PRTMPOR | Pouch material porosity (permeability) |
| DESIGN PARAMETER TESTING |
| 1900 | L/m^2/s | 1900 | 1900 | L/m^2/s | 1 | Week 0 | 1 | 67 | TOB17 | PT | SNUS-77 | 6 |
| NICTDSRT | Nicotine dissolution rate |
| DESIGN PARAMETER TESTING |
| 18 | %/min | 18 | 18 | %/min | 1 | Week 0 | 1 |
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