This example shows data for 1 animal subject, where only the minimal amount of timing information was readily available electronically. The subject was dosed daily and sampled for 2 profiles, starting day 1 and day 14. A full profile was obtained from the subject on both occasions and analyzed for parent compound and 2 metabolites.
PC PP Cross-domain Example 2: PC
At a minimum, the nominal timing variables required for the analysis are PCNOMDY, PCTPTREF, and PCELTM; these timing variables have been populated, but PCDTC is null. PCRFTDTC is populated with only the date of dose as the time was not recorded in a manner readily available electronically. Although not crucial for the analysis, PCTPT was recorded and therefore populated in this example.
In this example, the sponsor chose to populate PCTPTNUM with a simple sequential sorting order; therefore, no timing information can be assumed from the data represented in this variable.
In the case of duration dosing (e.g., continuous infusion), all records can only have 1 reference time point; this must be consistent (i.e., always work from the start of the dose, or always work from the end of dose). If the end of dosing is used as the reference time point, then start time point = -PT1H for 1 hour infusion and immediate postdose would be PT0H.
The example shows the best practice of using PCCAT to differentiate in the dataset between the parent and metabolite. It also shows the best practice of populating PCNAM.
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Rows 1-4, 6-10, 12-19, 21-26: | Show example concentration data and are provided for context. | | Show that when a result is BLQ in PCSTRESC, then both PCSTRESU and PCLLOQ should be populated; and as described in the assumptions. PCELTM for predose values is represented as "PT0H" because scientific data usage takes priority over study plan; therefore, predose values are typically set to zero for statistics and graphing. | | Rows 5, 11: | Show that when PCORRES is null and PCSTAT=NOT DONE, then PCSTRESU and PCLLOQ can be populated. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCSTAT | PCREASND | PCNAM | PCSPEC | PCBLFL | PCLLOQ | PCEXCLFL | PCREASEX | PCNOMDY | PCDTC | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
|---|
| 1 | 5311016 | PC | 5311016-101 | 1 | A9876543 | ABC9876543 | PARENT | 3000 | ng/mL | 3000 | 3000 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 0H30MIN | 1 | PT30M | Day 1 dose | 2018-01-01 | | 2 | 5311016 | PC | 5311016-101 | 3 | A9876543 | ABC9876543 | PARENT | 6240 | ng/mL | 6240 | 6240 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 1H | 2 | PT1H | Day 1 dose | 2018-01-01 | | 3 | 5311016 | PC | 5311016-101 | 5 | A9876543 | ABC9876543 | PARENT | 6950 | ng/mL | 6950 | 6950 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 2H | 3 | PT2H | Day 1 dose | 2018-01-01 | | 4 | 5311016 | PC | 5311016-101 | 7 | A9876543 | ABC9876543 | PARENT | 3630 | ng/mL | 3630 | 3630 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 4H | 4 | PT4H | Day 1 dose | 2018-01-01 | | 5 | 5311016 | PC | 5311016-101 | 9 | A9876543 | ABC9876543 | PARENT |
| ng/mL |
|
| ng/mL | NOT DONE | MISSING SAMPLE | ACME INC | PLASMA |
| 1 |
|
| 1 |
| 8H | 5 | PT8H | Day 1 dose | 2018-01-01 | | 6 | 5311016 | PC | 5311016-101 | 11 | A9876543 | ABC9876543 | PARENT | 27 | ng/mL | 27 | 27 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 24H | 6 | PT24H | Day 1 dose | 2018-01-01 | | 7 | 5311016 | PC | 5311016-101 | 2 | A9871234 | ABC9871234 | METABOLITE | 6680 | ng/mL | 6680 | 6680 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 0H30MIN | 1 | PT30M | Day 1 dose | 2018-01-01 | | 8 | 5311016 | PC | 5311016-101 | 4 | A9871234 | ABC9871234 | METABOLITE | 11700 | ng/mL | 11700 | 11700 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 1H | 2 | PT1H | Day 1 dose | 2018-01-01 | | 9 | 5311016 | PC | 5311016-101 | 6 | A9871234 | ABC9871234 | METABOLITE | 14200 | ng/mL | 14200 | 14200 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 2H | 3 | PT2H | Day 1 dose | 2018-01-01 | | 10 | 5311016 | PC | 5311016-101 | 8 | A9871234 | ABC9871234 | METABOLITE | 13900 | ng/mL | 13900 | 13900 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 4H | 4 | PT4H | Day 1 dose | 2018-01-01 | | 11 | 5311016 | PC | 5311016-101 | 10 | A9871234 | ABC9871234 | METABOLITE |
| ng/mL |
|
| ng/mL | NOT DONE | MISSING SAMPLE | ACME INC | PLASMA |
| 1 |
|
| 1 |
| 8H | 5 | PT8H | Day 1 dose | 2018-01-01 | | 12 | 5311016 | PC | 5311016-101 | 12 | A9871234 | ABC9871234 | METABOLITE | 90.1 | ng/mL | 90.1 | 90.1 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 1 |
| 24H | 6 | PT24H | Day 1 dose | 2018-01-01 | | 13 | 5311016 | PC | 5311016-101 | 13 | A9876543 | ABC9876543 | PARENT | <1 | ng/mL | BLQ |
| ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| PREDOSE | 1 | PT0H | Day 14 dose | 2018-01-14 | | 14 | 5311016 | PC | 5311016-101 | 15 | A9876543 | ABC9876543 | PARENT | 2970 | ng/mL | 2970 | 2970 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 0H30MIN | 2 | PT30M | Day 14 dose | 2018-01-14 | | 15 | 5311016 | PC | 5311016-101 | 17 | A9876543 | ABC9876543 | PARENT | 6270 | ng/mL | 6270 | 6270 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 1H | 3 | PT1H | Day 14 dose | 2018-01-14 | | 16 | 5311016 | PC | 5311016-101 | 19 | A9876543 | ABC9876543 | PARENT | 6290 | ng/mL | 6290 | 6290 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 2H | 4 | PT2H | Day 14 dose | 2018-01-14 | | 17 | 5311016 | PC | 5311016-101 | 21 | A9876543 | ABC9876543 | PARENT | 3170 | ng/mL | 3170 | 3170 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 4H | 5 | PT4H | Day 14 dose | 2018-01-14 | | 18 | 5311016 | PC | 5311016-101 | 23 | A9876543 | ABC9876543 | PARENT | 1550 | ng/mL | 1550 | 1550 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 8H | 6 | PT8H | Day 14 dose | 2018-01-14 | | 5311016 | PC | 5311016-101 | 25 | A9876543 | ABC9876543 | PARENT | 49.5 | ng/mL | 49.5 | 49.5 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 24H | 7 | PT24H | Day 14 dose | 2018-01-14 | | 20 | 5311016 | PC | 5311016-101 | 14 | A9871234 | ABC9871234 | METABOLITE | <1 | ng/mL | BLQ |
| ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| PREDOSE | 1 | PT0H | Day 14 dose | 2018-01-14 | | 21 | 5311016 | PC | 5311016-101 | 16 | A9871234 | ABC9871234 | METABOLITE | 3350 | ng/mL | 3350 | 3350 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 0H30MIN | 2 | PT30M | Day 14 dose | 2018-01-14 | | 22 | 5311016 | PC | 5311016-101 | 18 | A9871234 | ABC9871234 | METABOLITE | 8370 | ng/mL | 8370 | 8370 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 1H | 3 | PT1H | Day 14 dose | 2018-01-14 | | 23 | 5311016 | PC | 5311016-101 | 20 | A9871234 | ABC9871234 | METABOLITE | 14800 | ng/mL | 14800 | 14800 | ng/mL |
|
| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 2H | 4 | PT2H | Day 14 dose | 2018-01-14 | | 24 | 5311016 | PC | 5311016-101 | 22 | A9871234 | ABC9871234 | METABOLITE | 11900 | ng/mL | 11900 | 11900 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 4H | 5 | PT4H | Day 14 dose | 2018-01-14 | | 25 | 5311016 | PC | 5311016-101 | 24 | A9871234 | ABC9871234 | METABOLITE | 8610 | ng/mL | 8610 | 8610 | ng/mL |
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| ACME INC | PLASMA |
| 1 |
|
| 14 |
| 8H | 6 | PT8H | Day 14 dose | 2018-01-14 | | 26 | 5311016 | PC | 5311016-101 | 26 | A9871234 | ABC9871234 | METABOLITE | 124 | ng/mL | 124 | 124 | ng/mL |
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| ACME INC | PLASMA |
| 1 | Y | Concentration result excluded due to hemolysis | 14 |
| 24H | 7 | PT24H | Day 14 dose | 2018-01-14 |
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PC PP Cross-domain Example 2: PP
This example shows how PPTPTREF relates back to the PCTPTREF in the PC domain.
For the dose date/time, the date is known, but not the exact time; therefore, PPRFTDTC is populated with the data portion only.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSPEC | PPNOMDY | PPTPTREF | PPRFTDTC | PPSTINT | PPENINT |
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| 1 | 5311016 | PP | 5311016-101 | 1 | AUCINT | AUC from T1 to T2 | ABC9876543 | PARENT | 56805 | h*ng/mL | 56805 | 56805 | h*ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 | PT0H | PT24H | | 2 | 5311016 | PP | 5311016-101 | 2 | CMAX | Max Conc | ABC9876543 | PARENT | 6950 | ng/mL | 6950 | 6950 | ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 |
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| | 3 | 5311016 | PP | 5311016-101 | 3 | TMAX | Max Conc | ABC9876543 | PARENT | 2 | h | 2 | 2 | h | PLASMA | 1 | Day 1 dose | 2018-01-01 |
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| | 4 | 5311016 | PP | 5311016-101 | 4 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9876543 | PARENT | 5681 | h*ng/mL/(mg/kg) | 5681 | 5681 | h*ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-01 | PT0H | PT24H | | 5 | 5311016 | PP | 5311016-101 | 5 | CMAXD | Max Conc Norm by Dose | ABC9876543 | PARENT | 695 | ng/mL/(mg/kg) | 695 | 695 | ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-01 |
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| | 6 | 5311016 | PP | 5311016-101 | 6 | AUCINT | AUC from T1 to T2 | ABC9876543 | PARENT | 41029 | h*ng/mL | 41029 | 41029 | h*ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-01 | PT0H | PT24H | | 7 | 5311016 | PP | 5311016-101 | 7 | CMAX | Max Conc | ABC9876543 | PARENT | 6290 | ng/mL | 6290 | 6290 | ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-01 |
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| | 8 | 5311016 | PP | 5311016-101 | 8 | TMAX | Time of CMAX | ABC9876543 | PARENT | 2 | h | 2 | 2 | h | PLASMA | 14 | Day 14 dose | 2018-01-01 |
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| | 9 | 5311016 | PP | 5311016-101 | 9 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9876543 | PARENT | 4103 | h*ng/mL/(mg/kg) | 4103 | 4103 | h*ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-01 | PT0H | PT24H | | 10 | 5311016 | PP | 5311016-101 | 10 | CMAXD | Max Conc Norm by Dose | ABC9876543 | PARENT | 629 | ng/mL/(mg/kg) | 629 | 629 | ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-01 |
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| | 11 | 5311016 | PP | 5311016-101 | 11 | AUCINT | AUC from T1 to T2 | ABC9871234 | METABOLITE | 187216 | h*ng/mL | 187216 | 187216 | h*ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 | PT0H | PT24H | | 12 | 5311016 | PP | 5311016-101 | 12 | CMAX | Max Conc | ABC9871234 | METABOLITE | 14200 | ng/mL | 14200 | 14200 | ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 |
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| | 13 | 5311016 | PP | 5311016-101 | 13 | TMAX | Time of CMAX | ABC9871234 | METABOLITE | 2 | h | 2 | 2 | h | PLASMA | 1 | Day 1 dose | 2018-01-14 |
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| | 14 | 5311016 | PP | 5311016-101 | 14 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9871234 | METABOLITE | 18722 | h*ng/mL/(mg/kg) | 18722 | 18722 | h*ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-14 | PT0H | PT24H | | 15 | 5311016 | PP | 5311016-101 | 15 | CMAXD | Max Conc Norm by Dose | ABC9871234 | METABOLITE | 1420 | ng/mL/(mg/kg) | 1420 | 1420 | ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-14 |
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| | 16 | 5311016 | PP | 5311016-101 | 16 | AUCINT | AUC from T1 to T2 | ABC9871234 | METABOLITE | 152945 | h*ng/mL | 152945 | 152945 | h*ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-14 | PT0H | PT24H | | 17 | 5311016 | PP | 5311016-101 | 17 | CMAX | Max Conc | ABC9871234 | METABOLITE | 14800 | ng/mL | 14800 | 14800 | ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-14 |
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| | 18 | 5311016 | PP | 5311016-101 | 18 | TMAX | Time of CMAX | ABC9871234 | METABOLITE | 2 | h | 2 | 2 | h | PLASMA | 14 | Day 14 dose | 2018-01-14 |
|
| | 19 | 5311016 | PP | 5311016-101 | 19 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9871234 | METABOLITE | 15295 | h*ng/mL/(mg/kg) | 15295 | 15295 | h*ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-14 | PT0H | PT24H | | 20 | 5311016 | PP | 5311016-101 | 20 | CMAXD | Max Conc Norm by Dose | ABC9871234 | METABOLITE | 1480 | ng/mL/(mg/kg) | 1480 | 1480 | ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-14 |
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PC PP Cross-domain Example 2: SUPPPC
This example shows a SUPPPC 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 | 5311016 | PC | 5311016-101 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
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