This example shows data for 1 animal subject, where all timing variables are populated as the information was readily available electronically. The subject was dosed daily and sampled for 2 profiles, starting day 1 and day 7. A full profile was obtained from the subject on both occasions and analyzed for parent compound (PCTESTCD = XYZ123) and 2 metabolites (PCTESTCD = XYZ345 and XYZ456).
PC PP Cross-domain Example 1: EX
The Exposure (EX) records are provided to show the relationship between the time recorded in the dosing records (EXSTDTC) and the PCRFTDTC and PPRFTDTC.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXRTV | EXVAMT | EXVAMTU | EXSTDTC | EXSTDY |
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1 | ABC-123 | EX | ABC-123-1001 | 1 | XYZ-123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-20T09:49:39 | 1 | 2 | ABC-123 | EX | ABC-123-1001 | 2 | XYZ-123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-21T09:36:08 | 2 | 3 | ABC-123 | EX | ABC-123-1001 | 3 | XYZ-123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-22T09:24:26 | 3 | 4 | ABC-123 | EX | ABC-123-1001 | 4 | XYZ-123 | 2.7 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-23T09:55:14 | 4 | 5 | ABC-123 | EX | ABC-123-1001 | 5 | XYZ-123 | 2.7 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-24T09:42:59 | 5 | 6 | ABC-123 | EX | ABC-123-1001 | 6 | XYZ-123 | 2.7 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-25T09:15:16 | 6 | 7 | ABC-123 | EX | ABC-123-1001 | 7 | XYZ-123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123-01 | Saline | 5 | mL | 2017-06-26T09:08:40 | 7 | |
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PC PP Cross-domain Example 1: PC
In this example, the sponsor chose to populate PCTPTNUM with a value representing the number of hours postdose. The sponsor populated PCCAT with ANALYTE and PCSCAT to differentiate between PARENT and METABOLITE.
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Rows 1, 9-10, 19-20: | Show that when a measurement is identified as being below a limit of quantitation threshold in PCSTRESC, PCLLOQ should be populated, and PCSTRESU must be populated. | Rows 2-8, 11-18, 21-36: | Show measurements where all result variables (PCORRES, PCSTRESC, PCSTRESN) are populated because they are not below the limit of quantitation. Although these values are not below the lower limit of quantitation, PCLLOQ is populated. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCSCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCNAM | PCSPEC | PCMETHOD | PCLLOQ | PCDTC | PCDY | PCNOMDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
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1 | ABC-123 | PC | ABC-123-1001 | 1 | XYZ123 | XYZ-123 | ANALYTE | PARENT | <LLOQ | ng/mL | BLQ |
| ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T09:49:00 | 1 | 1 | Predose | 0 | PT0H | Day 1 Dose | 2017-06-20T09:49:39 | 2 | ABC-123 | PC | ABC-123-1001 | 2 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 0.700 | ng/mL | 0.700 | 0.7 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T10:04:00 | 1 | 1 | 0.25 hour postdose | 0.25 | PT0.25H | Day 1 Dose | 2017-06-20T09:49:39 | 3 | ABC-123 | PC | ABC-123-1001 | 3 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 8.1 | ng/mL | 8.1 | 8.1 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T10:19:00 | 1 | 1 | 0.5 hour postdose | 0.5 | PT0.5H | Day 1 Dose | 2017-06-20T09:49:39 | 4 | ABC-123 | PC | ABC-123-1001 | 4 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 44.0 | ng/mL | 44.0 | 44 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T10:44:00 | 1 | 1 | 1 hour postdose | 1 | PT1H | Day 1 Dose | 2017-06-20T09:49:39 | 5 | ABC-123 | PC | ABC-123-1001 | 5 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 108 | ng/mL | 108 | 108 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T11:52:00 | 1 | 1 | 2 hours postdose | 2 | PT2H | Day 1 Dose | 2017-06-20T09:49:39 | 6 | ABC-123 | PC | ABC-123-1001 | 6 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 32.3 | ng/mL | 32.3 | 32.3 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T13:56:00 | 1 | 1 | 4 hours postdose | 4 | PT4H | Day 1 Dose | 2017-06-20T09:49:39 | 7 | ABC-123 | PC | ABC-123-1001 | 7 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 4.75 | ng/mL | 4.75 | 4.75 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T17:53:00 | 1 | 1 | 8 hours postdose | 8 | PT8H | Day 1 Dose | 2017-06-20T09:49:39 | 8 | ABC-123 | PC | ABC-123-1001 | 8 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 2.01 | ng/mL | 2.01 | 2.01 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T21:27:00 | 1 | 1 | 12 hours postdose | 12 | PT12H | Day 1 Dose | 2017-06-20T09:49:39 | 9 | ABC-123 | PC | ABC-123-1001 | 9 | XYZ123 | XYZ-123 | ANALYTE | PARENT | <LLOQ | ng/mL | BLQ |
| ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-21T09:53:00 | 2 | 1 | 24 hours postdose | 24 | PT24H | Day 1 Dose | 2017-06-20T09:49:39 | 10 | ABC-123 | PC | ABC-123-1001 | 10 | XYZ123 | XYZ-123 | ANALYTE | PARENT | <LLOQ | ng/mL | BLQ |
| ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T09:07:00 | 7 | 7 | Predose | 0 | PT0H | Day 7 Dose | 2017-06-26T09:08:40 | 11 | ABC-123 | PC | ABC-123-1001 | 11 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 7.69 | ng/mL | 7.69 | 7.69 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T09:23:00 | 7 | 7 | 0.25 hour postdose | 0.25 | PT0.25H | Day 7 Dose | 2017-06-26T09:08:40 | 12 | ABC-123 | PC | ABC-123-1001 | 12 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 39.8 | ng/mL | 39.8 | 39.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T09:37:00 | 7 | 7 | 0.5 hour postdose | 0.5 | PT0.5H | Day 7 Dose | 2017-06-26T09:08:40 | 13 | ABC-123 | PC | ABC-123-1001 | 13 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 140 | ng/mL | 140 | 140 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T10:06:00 | 7 | 7 | 1 hour postdose | 1 | PT1H | Day 7 Dose | 2017-06-26T09:08:40 | 14 | ABC-123 | PC | ABC-123-1001 | 14 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 116 | ng/mL | 116 | 116 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T10:56:00 | 7 | 7 | 2 hours postdose | 2 | PT2H | Day 7 Dose | 2017-06-26T09:08:40 | 15 | ABC-123 | PC | ABC-123-1001 | 15 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 52.2 | ng/mL | 52.2 | 52.2 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T13:08:00 | 7 | 7 | 4 hours postdose | 4 | PT4H | Day 7 Dose | 2017-06-26T09:08:40 | 16 | ABC-123 | PC | ABC-123-1001 | 16 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 18.3 | ng/mL | 18.3 | 18.3 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T17:07:00 | 7 | 7 | 8 hours postdose | 8 | PT8H | Day 7 Dose | 2017-06-26T09:08:40 | 17 | ABC-123 | PC | ABC-123-1001 | 17 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 14.4 | ng/mL | 14.4 | 14.4 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T21:26:00 | 7 | 7 | 12 hours postdose | 12 | PT12H | Day 7 Dose | 2017-06-26T09:08:40 | 18 | ABC-123 | PC | ABC-123-1001 | 18 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 2.01 | ng/mL | 2.01 | 2.01 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-27T08:13:00 | 8 | 7 | 24 hours postdose | 24 | PT24H | Day 7 Dose | 2017-06-26T09:08:40 | 19 | ABC-123 | PC | ABC-123-1001 | 19 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | <LLOQ | ng/mL | BLQ |
| ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T09:49:00 | 1 | 1 | Predose | 0 | PT0H | Day 1 Dose | 2017-06-20T09:49:39 | 20 | ABC-123 | PC | ABC-123-1001 | 20 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | <LLOQ | ng/mL | BLQ |
| ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T10:04:00 | 1 | 1 | 0.25 hour postdose | 0.25 | PT0.25H | Day 1 Dose | 2017-06-20T09:49:39 | 21 | ABC-123 | PC | ABC-123-1001 | 21 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 11.6 | ng/mL | 11.6 | 11.6 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T10:19:00 | 1 | 1 | 0.5 hour postdose | 0.5 | PT0.5H | Day 1 Dose | 2017-06-20T09:49:39 | 22 | ABC-123 | PC | ABC-123-1001 | 22 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 78.7 | ng/mL | 78.7 | 78.7 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T10:44:00 | 1 | 1 | 1 hour postdose | 1 | PT1H | Day 1 Dose | 2017-06-20T09:49:39 | 23 | ABC-123 | PC | ABC-123-1001 | 23 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 699 | ng/mL | 699 | 699 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T11:52:00 | 1 | 1 | 2 hours postdose | 2 | PT2H | Day 1 Dose | 2017-06-20T09:49:39 | 24 | ABC-123 | PC | ABC-123-1001 | 24 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 205 | ng/mL | 205 | 205 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T13:56:00 | 1 | 1 | 4 hours postdose | 4 | PT4H | Day 1 Dose | 2017-06-20T09:49:39 | 25 | ABC-123 | PC | ABC-123-1001 | 25 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 21.8 | ng/mL | 21.8 | 21.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T17:53:00 | 1 | 1 | 8 hours postdose | 8 | PT8H | Day 1 Dose | 2017-06-20T09:49:39 | 26 | ABC-123 | PC | ABC-123-1001 | 26 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 6.20 | ng/mL | 6.20 | 6.2 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-20T21:27:00 | 1 | 1 | 12 hours postdose | 12 | PT12H | Day 1 Dose | 2017-06-20T09:49:39 | 27 | ABC-123 | PC | ABC-123-1001 | 27 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 1.66 | ng/mL | 1.66 | 1.66 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-21T09:53:00 | 2 | 1 | 24 hours postdose | 24 | PT24H | Day 1 Dose | 2017-06-20T09:49:39 | 28 | ABC-123 | PC | ABC-123-1001 | 28 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 2.05 | ng/mL | 2.05 | 2.05 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T09:07:00 | 7 | 7 | Predose | 0 | PT0H | Day 7 Dose | 2017-06-26T09:08:40 | 29 | ABC-123 | PC | ABC-123-1001 | 29 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 9.29 | ng/mL | 9.29 | 9.29 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T09:23:00 | 7 | 7 | 0.25 hour postdose | 0.25 | PT0.25H | Day 7 Dose | 2017-06-26T09:08:40 | 30 | ABC-123 | PC | ABC-123-1001 | 30 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 39.8 | ng/mL | 39.8 | 39.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T09:37:00 | 7 | 7 | 0.5 hour postdose | 0.5 | PT0.5H | Day 7 Dose | 2017-06-26T09:08:40 | 31 | ABC-123 | PC | ABC-123-1001 | 31 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 89.6 | ng/mL | 89.6 | 89.6 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T10:06:00 | 7 | 7 | 1 hour postdose | 1 | PT1H | Day 7 Dose | 2017-06-26T09:08:40 | 32 | ABC-123 | PC | ABC-123-1001 | 32 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 92.8 | ng/mL | 92.8 | 92.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T10:56:00 | 7 | 7 | 2 hours postdose | 2 | PT2H | Day 7 Dose | 2017-06-26T09:08:40 | 33 | ABC-123 | PC | ABC-123-1001 | 33 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 56.8 | ng/mL | 56.8 | 56.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T13:08:00 | 7 | 7 | 4 hours postdose | 4 | PT4H | Day 7 Dose | 2017-06-26T09:08:40 | 34 | ABC-123 | PC | ABC-123-1001 | 34 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 15.2 | ng/mL | 15.2 | 15.2 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T17:07:00 | 7 | 7 | 8 hours postdose | 8 | PT8H | Day 7 Dose | 2017-06-26T09:08:40 | 35 | ABC-123 | PC | ABC-123-1001 | 35 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 10.8 | ng/mL | 10.8 | 10.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-26T21:26:00 | 7 | 7 | 12 hours postdose | 12 | PT12H | Day 7 Dose | 2017-06-26T09:08:40 | 36 | ABC-123 | PC | ABC-123-1001 | 36 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 3.66 | ng/mL | 3.66 | 3.66 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06-27T08:13:00 | 8 | 7 | 24 hours postdose | 24 | PT24H | Day 7 Dose | 2017-06-26T09:08:40 |
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PC PP Cross-domain Example 1: PP
In this example, PPTPREF has been populated with values giving the day of dose. In this case there is only 1 daily dose; therefore, PPTPTREF populated with “Day 1 Dose” is sufficient to explain the reference and matches PCTPTREF.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSTAT | PPREASND | PPSPEC | PPNOMDY | PPTPTREF | PPRFTDTC | PPSTINT | PPENINT |
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1 | ABC-123 | PP | ABC-123-1001 | 1 | TMAX | Time of CMAX | XYZ-123 | NON-COMPARTMENTAL | 2 | h | 2 | 2 | h |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 |
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| 2 | ABC-123 | PP | ABC-123-1001 | 2 | CMAX | Max Conc | XYZ-123 | NON-COMPARTMENTAL | 108 | ng/mL | 108 | 108 | ng/mL |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 |
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| 3 | ABC-123 | PP | ABC-123-1001 | 3 | AUCLST | AUC to Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 318 | h*ng/mL | 318 | 318 | h*ng/mL |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 |
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| 4 | ABC-123 | PP | ABC-123-1001 | 4 | TLST | Time of Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 12 | h | 12 | 12 | h |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 |
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| 5 | ABC-123 | PP | ABC-123-1001 | 5 | AUCINT | AUC from T1 to T2 | XYZ-123 | NON-COMPARTMENTAL | 330 | h*ng/mL | 330 | 330 | h*ng/mL |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | PT0H | PT24H | 6 | ABC-123 | PP | ABC-123-1001 | 6 | TMAX | Time of CMAX | XYZ-123 | NON-COMPARTMENTAL | 1 | h | 1 | 1 | h |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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| 7 | ABC-123 | PP | ABC-123-1001 | 7 | CMAX | Max Conc | XYZ-123 | NON-COMPARTMENTAL | 140 | ng/mL | 140 | 140 | ng/mL |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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| 8 | ABC-123 | PP | ABC-123-1001 | 8 | AUCLST | AUC to Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 653 | h*ng/mL | 653 | 653 | h*ng/mL |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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| 9 | ABC-123 | PP | ABC-123-1001 | 9 | TLST | Time of Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 24 | h | 24 | 24 | h |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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| 10 | ABC-123 | PP | ABC-123-1001 | 10 | AUCINT | AUC from T1 to T2 | XYZ-123 | NON-COMPARTMENTAL | 653 | h*ng/mL | 653 | 653 | h*ng/mL |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | PT0H | PT24H | 11 | ABC-123 | PP | ABC-123-1001 | 11 | ARCMAX | Accumulation Ratio Cmax | XYZ-123 | NON-COMPARTMENTAL | 1.30 | RATIO | 1.30 | 1.30 | RATIO |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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| 12 | ABC-123 | PP | ABC-123-1001 | 12 | AUCLST | AUC to Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 1874 | h*ng/mL | 1874 | 1874 | h*ng/mL |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 |
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| 13 | ABC-123 | PP | ABC-123-1001 | 13 | TLST | Time of Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 24 | h | 24 | 24 | h |
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| PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 |
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| 14 | ABC-123 | PP | ABC-123-1001 | 14 | AUCLST | AUC to Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 563 | h*ng/mL | 563 | 563 | h*ng/mL |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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| 15 | ABC-123 | PP | ABC-123-1001 | 15 | TLST | Time of Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 24 | h | 24 | 24 | h |
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| PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
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PC PP Cross-domain Example 1: SUPPPC
This example shows a SUPPC domain to specify the PCCALCN value used for the PC records where the result fell below the limit of quantitation.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | ABC-123 | PC | ABC-123-1001 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
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