This multi-domain example shows a PC domain for a rodent sparse sampling study of 9 animal subjects, where all timing information was readily available electronically. The subjects were dosed daily and sampled to construct 2 time-concentration profiles, with one referencing the day 1 dose and the other referencing the day 42 dose. The concentration data were then combined by reference dose (day 1 or day 42) to create composite rat exposures in the PP domain.
PC PP Cross-domain Example 3: PC
PCCAT and PCSCAT are not populated because there is only 1 value within PCTEST/PCTESTCD.
PCTPTNUM is intended to aid in sorting. In this example, it is populated with the chronological value of time in minutes between the PCTPT and PCTPTREF, even though PCELTM represents the equivalent time in hours.
This example shows a well constructed, informative PCTPT and PCTPTREF.
pc.xpt
pc.xpt
Row
STUDYID
DOMAIN
USUBJID
PCSEQ
PCTESTCD
PCTEST
PCCAT
PCSCAT
PCORRES
PCORRESU
PCSTRESC
PCSTRESN
PCSTRESU
PCNAM
PCSPEC
PCMETHOD
PCBLFL
PCLLOQ
PCNOMDY
PCDTC
PCDY
PCTPT
PCTPTNUM
PCELTM
PCTPTREF
PCRFTDTC
1
ABC-123
PC
ABC-123-2001
1
LMN123
LMN-123
0.856
ug/mL
0.856
0.856
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T09:10:45
42
Predose
0
PT0H
Day 42 Dose
2015-05-10T09:55:16
2
ABC-123
PC
ABC-123-2001
2
LMN123
LMN-123
28.9
ug/mL
28.9
28.9
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T11:56:02
42
2 hour postdose
120
PT2H
Day 42 Dose
2015-05-10T09:55:16
3
ABC-123
PC
ABC-123-2001
3
LMN123
LMN-123
0.559
ug/mL
0.559
0.559
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-11T09:55:28
43
24 hour postdose
1440
PT24H
Day 42 Dose
2015-05-10T09:55:16
4
ABC-123
PC
ABC-123-2002
1
LMN123
LMN-123
1.76
ug/mL
1.76
1.76
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T09:11:49
42
Predose
0
PT0H
Day 42 Dose
2015-05-10T09:56:06
5
ABC-123
PC
ABC-123-2002
2
LMN123
LMN-123
39
ug/mL
39
39
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T11:57:02
42
2 hour postdose
120
PT2H
Day 42 Dose
2015-05-10T09:56:06
6
ABC-123
PC
ABC-123-2002
3
LMN123
LMN-123
2.89
ug/mL
2.89
2.89
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-11T09:56:26
43
24 hour postdose
1440
PT24H
Day 42 Dose
2015-05-10T09:56:06
7
ABC-123
PC
ABC-123-2003
1
LMN123
LMN-123
0.646
ug/mL
0.646
0.646
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T09:12:53
42
Predose
0
PT0H
Day 42 Dose
2015-05-10T09:57:07
8
ABC-123
PC
ABC-123-2003
2
LMN123
LMN-123
33.9
ug/mL
33.9
33.9
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T11:58:04
42
2 hour postdose
120
PT2H
Day 42 Dose
2015-05-10T09:57:07
9
ABC-123
PC
ABC-123-2003
3
LMN123
LMN-123
0.39
ug/mL
0.39
0.39
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-11T09:57:50
43
24 hour postdose
1440
PT24H
Day 42 Dose
2015-05-10T09:57:07
10
ABC-123
PC
ABC-123-2004
1
LMN123
LMN-123
18.9
ug/mL
18.9
18.9
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T09:45:21
42
0.25 hour postdose
15
PT0.25H
Day 42 Dose
2015-05-10T09:30:08
11
ABC-123
PC
ABC-123-2004
2
LMN123
LMN-123
16.1
ug/mL
16.1
16.1
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T13:30:50
42
4 hour postdose
240
PT4H
Day 42 Dose
2015-05-10T09:30:08
12
ABC-123
PC
ABC-123-2004
3
LMN123
LMN-123
1.28
ug/mL
1.28
1.28
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-12T09:30:17
44
48 hour postdose
2880
PT48H
Day 42 Dose
2015-05-10T09:30:08
13
ABC-123
PC
ABC-123-2005
1
LMN123
LMN-123
20.8
ug/mL
20.8
20.8
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T09:46:10
42
0.25 hour postdose
15
PT0.25H
Day 42 Dose
2015-05-10T09:31:07
14
ABC-123
PC
ABC-123-2005
2
LMN123
LMN-123
18
ug/mL
18
18
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T13:32:04
42
4 hour postdose
240
PT4H
Day 42 Dose
2015-05-10T09:31:07
15
ABC-123
PC
ABC-123-2005
3
LMN123
LMN-123
17.8
ug/mL
17.8
17.8
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-12T09:31:42
44
48 hour postdose
2880
PT48H
Day 42 Dose
2015-05-10T09:31:07
16
ABC-123
PC
ABC-123-2006
1
LMN123
LMN-123
23.9
ug/mL
23.9
23.9
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T09:47:10
42
0.25 hour postdose
15
PT0.25H
Day 42 Dose
2015-05-10T09:32:07
17
ABC-123
PC
ABC-123-2006
2
LMN123
LMN-123
22.4
ug/mL
22.4
22.4
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T13:33:22
42
4 hour postdose
240
PT4H
Day 42 Dose
2015-05-10T09:32:07
18
ABC-123
PC
ABC-123-2006
3
LMN123
LMN-123
0.520
ug/mL
0.520
0.520
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-12T09:32:56
44
48 hour postdose
2880
PT48H
Day 42 Dose
2015-05-10T09:32:07
19
ABC-123
PC
ABC-123-2007
1
LMN123
LMN-123
46.9
ug/mL
46.9
46.9
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T10:30:02
42
1 hour postdose
60
PT1H
Day 42 Dose
2015-05-10T09:30:23
20
ABC-123
PC
ABC-123-2007
2
LMN123
LMN-123
3.45
ug/mL
3.45
3.45
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T17:25:17
42
8 hour postdose
480
PT8H
Day 42 Dose
2015-05-10T09:30:23
21
ABC-123
PC
ABC-123-2007
3
LMN123
LMN-123
BLQ (<0.200)
ug/mL
BLQ
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-14T09:32:45
46
96 hour postdose
5760
PT96H
Day 42 Dose
2015-05-10T09:30:23
22
ABC-123
PC
ABC-123-2008
1
LMN123
LMN-123
39.4
ug/mL
39.4
39.4
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T10:31:05
42
1 hour postdose
60
PT1H
Day 42 Dose
2015-05-10T09:31:26
23
ABC-123
PC
ABC-123-2008
2
LMN123
LMN-123
4.44
ug/mL
4.44
4.44
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T17:26:16
42
8 hour postdose
480
PT8H
Day 42 Dose
2015-05-10T09:31:26
24
ABC-123
PC
ABC-123-2008
3
LMN123
LMN-123
BLQ (<0.200)
ug/mL
BLQ
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-14T09:33:54
46
96 hour postdose
5760
PT96H
Day 42 Dose
2015-05-10T09:31:26
25
ABC-123
PC
ABC-123-2009
1
LMN123
LMN-123
45.1
ug/mL
45.1
45.1
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T10:32:22
42
1 hour postdose
60
PT1H
Day 42 Dose
2015-05-10T09:32:26
26
ABC-123
PC
ABC-123-2009
2
LMN123
LMN-123
3.16
ug/mL
3.16
3.16
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-10T17:27:41
42
8 hour postdose
480
PT8H
Day 42 Dose
2015-05-10T09:32:26
27
ABC-123
PC
ABC-123-2009
3
LMN123
LMN-123
BLQ (<0.200)
ug/mL
BLQ
ug/mL
LAB X
PLASMA
HPLC/MS/MS
0.2
42
2015-05-14T09:35:07
46
96 hour postdose
5760
PT96H
Day 42 Dose
2015-05-10T09:32:26
$warningHtml
PC PP Cross-domain Example 3: PP
PPRFTDTC can be null due to sparse sampling. Data can be grouped by PPNOMDY and PPTPTREF.
In sparse sampling scenarios where multiple subjects contribute to a toxicokinetic result, PC and PP records cannot be directly linked by the unique timestamp for the dosing event (i.e., where EXDTC = PCRFTDTC = PPRFTDTC). In such cases, PPRFTDTC can be left null. In the event that all subjects in a pool have the same reference time point date, it would also be acceptable to populate PPRFTDTC with the date (no time) that corresponds to the description in PPTPTREF.
In this example, even though all subjects in the pool shared the same date as the reference time point for the profile, the applicant chose to leave PPRFTDTC as null.
pp.xpt
pp.xpt
Row
STUDYID
DOMAIN
USUBJID
POOLID
PPSEQ
PPTESTCD
PPTEST
PPCAT
PPORRES
PPORRESU
PPSTRESC
PPSTRESN
PPSTRESU
PPSTAT
PPREASND
PPSPEC
PPNOMDY
PPTPTREF
PPRFTDTC
1
ABC-123
PP
PP-Group 2
1
CMAX
Max Conc
LMN-123
43.8
ug/mL
43.8
43.8
ug/mL
PLASMA
42
Day 42 Dose
2
ABC-123
PP
PP-Group 2
2
CMAXD
Max Conc Norm by Dose
LMN-123
0.438
ug/mL/(mg/kg)
0.438
0.438
ug/mL/(mg/kg)
PLASMA
42
Day 42 Dose
3
ABC-123
PP
PP-Group 2
3
TMAX
Time of CMAX
LMN-123
1
h
1
1
h
PLASMA
42
Day 42 Dose
4
ABC-123
PP
PP-Group 2
4
TLST
Time of Last Nonzero Conc
LMN-123
48
h
48
48
h
PLASMA
42
Day 42 Dose
5
ABC-123
PP
PP-Group 2
5
AUCLST
AUC to Last Nonzero Conc
LMN-123
297
h*ug/mL
297
297
h*ug/mL
PLASMA
42
Day 42 Dose
6
ABC-123
PP
PP-Group 2
6
AUCLSTD
AUC to Last Nonzero Conc Norm by Dose
LMN-123
2.97
h*ug/mL/(mg/kg)
2.97
2.97
h*ug/mL/(mg/kg)
PLASMA
42
Day 42 Dose
7
ABC-123
PP
PP-Group 2
7
LAMZHL
Half-Life Lambda z
LMN-123
NOT DONE
Not reported due to insufficient plasma concentration data
PLASMA
42
Day 42 Dose
$warningHtml
PC PP Cross-domain Example 3: 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.