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

RowSTUDYIDDOMAINUSUBJIDPCSEQPCTESTCDPCTESTPCCATPCSCATPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCNAMPCSPECPCMETHODPCBLFLPCLLOQPCNOMDYPCDTCPCDYPCTPTPCTPTNUMPCELTMPCTPTREFPCRFTDTC
1ABC-123PCABC-123-20011LMN123LMN-123

0.856ug/mL0.8560.856ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T09:10:4542Predose0PT0HDay 42 Dose2015-05-10T09:55:16
2ABC-123PCABC-123-20012LMN123LMN-123

28.9ug/mL28.928.9ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T11:56:02422 hour postdose120PT2HDay 42 Dose2015-05-10T09:55:16
3ABC-123PCABC-123-20013LMN123LMN-123

0.559ug/mL0.5590.559ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-11T09:55:284324 hour postdose1440PT24HDay 42 Dose2015-05-10T09:55:16
4ABC-123PCABC-123-20021LMN123LMN-123

1.76ug/mL1.761.76ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T09:11:4942Predose0PT0HDay 42 Dose2015-05-10T09:56:06
5ABC-123PCABC-123-20022LMN123LMN-123

39ug/mL3939ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T11:57:02422 hour postdose120PT2HDay 42 Dose2015-05-10T09:56:06
6ABC-123PCABC-123-20023LMN123LMN-123

2.89ug/mL2.892.89ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-11T09:56:264324 hour postdose1440PT24HDay 42 Dose2015-05-10T09:56:06
7ABC-123PCABC-123-20031LMN123LMN-123

0.646ug/mL0.6460.646ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T09:12:5342Predose0PT0HDay 42 Dose2015-05-10T09:57:07
8ABC-123PCABC-123-20032LMN123LMN-123

33.9ug/mL33.933.9ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T11:58:04422 hour postdose120PT2HDay 42 Dose2015-05-10T09:57:07
9ABC-123PCABC-123-20033LMN123LMN-123

0.39ug/mL0.390.39ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-11T09:57:504324 hour postdose1440PT24HDay 42 Dose2015-05-10T09:57:07
10ABC-123PCABC-123-20041LMN123LMN-123

18.9ug/mL18.918.9ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T09:45:21420.25 hour postdose15PT0.25HDay 42 Dose2015-05-10T09:30:08
11ABC-123PCABC-123-20042LMN123LMN-123

16.1ug/mL16.116.1ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T13:30:50424 hour postdose240PT4HDay 42 Dose2015-05-10T09:30:08
12ABC-123PCABC-123-20043LMN123LMN-123

1.28ug/mL1.281.28ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-12T09:30:174448 hour postdose2880PT48HDay 42 Dose2015-05-10T09:30:08
13ABC-123PCABC-123-20051LMN123LMN-123

20.8ug/mL20.820.8ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T09:46:10420.25 hour postdose15PT0.25HDay 42 Dose2015-05-10T09:31:07
14ABC-123PCABC-123-20052LMN123LMN-123

18ug/mL1818ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T13:32:04424 hour postdose240PT4HDay 42 Dose2015-05-10T09:31:07
15ABC-123PCABC-123-20053LMN123LMN-123

17.8ug/mL17.817.8ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-12T09:31:424448 hour postdose2880PT48HDay 42 Dose2015-05-10T09:31:07
16ABC-123PCABC-123-20061LMN123LMN-123

23.9ug/mL23.923.9ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T09:47:10420.25 hour postdose15PT0.25HDay 42 Dose2015-05-10T09:32:07
17ABC-123PCABC-123-20062LMN123LMN-123

22.4ug/mL22.422.4ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T13:33:22424 hour postdose240PT4HDay 42 Dose2015-05-10T09:32:07
18ABC-123PCABC-123-20063LMN123LMN-123

0.520ug/mL0.5200.520ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-12T09:32:564448 hour postdose2880PT48HDay 42 Dose2015-05-10T09:32:07
19ABC-123PCABC-123-20071LMN123LMN-123

46.9ug/mL46.946.9ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T10:30:02421 hour postdose60PT1HDay 42 Dose2015-05-10T09:30:23
20ABC-123PCABC-123-20072LMN123LMN-123

3.45ug/mL3.453.45ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T17:25:17428 hour postdose480PT8HDay 42 Dose2015-05-10T09:30:23
21ABC-123PCABC-123-20073LMN123LMN-123

BLQ (<0.200)ug/mLBLQ
ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-14T09:32:454696 hour postdose5760PT96HDay 42 Dose2015-05-10T09:30:23
22ABC-123PCABC-123-20081LMN123LMN-123

39.4ug/mL39.439.4ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T10:31:05421 hour postdose60PT1HDay 42 Dose2015-05-10T09:31:26
23ABC-123PCABC-123-20082LMN123LMN-123

4.44ug/mL4.444.44ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T17:26:16428 hour postdose480PT8HDay 42 Dose2015-05-10T09:31:26
24ABC-123PCABC-123-20083LMN123LMN-123

BLQ (<0.200)ug/mLBLQ
ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-14T09:33:544696 hour postdose5760PT96HDay 42 Dose2015-05-10T09:31:26
25ABC-123PCABC-123-20091LMN123LMN-123

45.1ug/mL45.145.1ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T10:32:22421 hour postdose60PT1HDay 42 Dose2015-05-10T09:32:26
26ABC-123PCABC-123-20092LMN123LMN-123

3.16ug/mL3.163.16ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-10T17:27:41428 hour postdose480PT8HDay 42 Dose2015-05-10T09:32:26
27ABC-123PCABC-123-20093LMN123LMN-123

BLQ (<0.200)ug/mLBLQ
ug/mLLAB XPLASMAHPLC/MS/MS
0.2422015-05-14T09:35:074696 hour postdose5760PT96HDay 42 Dose2015-05-10T09:32:26
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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

RowSTUDYIDDOMAINUSUBJIDPOOLIDPPSEQPPTESTCDPPTESTPPCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSTATPPREASNDPPSPECPPNOMDYPPTPTREFPPRFTDTC
1ABC-123PP
PP-Group 21CMAXMax ConcLMN-12343.8ug/mL43.843.8ug/mL

PLASMA42Day 42 Dose
2ABC-123PP
PP-Group 22CMAXDMax Conc Norm by DoseLMN-1230.438ug/mL/(mg/kg)0.4380.438ug/mL/(mg/kg)

PLASMA42Day 42 Dose
3ABC-123PP
PP-Group 23TMAXTime of CMAXLMN-1231h11h

PLASMA42Day 42 Dose
4ABC-123PP
PP-Group 24TLSTTime of Last Nonzero ConcLMN-12348h4848h

PLASMA42Day 42 Dose
5ABC-123PP
PP-Group 25AUCLSTAUC to Last Nonzero ConcLMN-123297h*ug/mL297297h*ug/mL

PLASMA42Day 42 Dose
6ABC-123PP
PP-Group 26AUCLSTDAUC to Last Nonzero Conc Norm by DoseLMN-1232.97h*ug/mL/(mg/kg)2.972.97h*ug/mL/(mg/kg)

PLASMA42Day 42 Dose
7ABC-123PP
PP-Group 27LAMZHLHalf-Life Lambda zLMN-123




NOT DONENot reported due to insufficient plasma concentration dataPLASMA42Day 42 Dose
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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.

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supppc.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1ABC-123PCABC-123-2007PCSTRESCBLQPCCALCNNumeric Interpretation for Calculations0DERIVED
2ABC-123PCABC-123-2008PCSTRESCBLQPCCALCNNumeric Interpretation for Calculations0DERIVED
3ABC-123PCABC-123-2009PCSTRESCBLQPCCALCNNumeric Interpretation for Calculations0DERIVED
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PC PP Cross-domain Example 3: POOLDEF

This example shows how the subjects were pooled.

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pooldef.xpt

RowSTUDYIDPOOLIDUSUBJID
1ABC-123PP-Group 2ABC-123-2001
2ABC-123PP-Group 2ABC-123-2002
3ABC-123PP-Group 2ABC-123-2003
4ABC-123PP-Group 2ABC-123-2004
5ABC-123PP-Group 2ABC-123-2005
6ABC-123PP-Group 2ABC-123-2006
7ABC-123PP-Group 2ABC-123-2007
8ABC-123PP-Group 2ABC-123-2008
9ABC-123PP-Group 2ABC-123-2009
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