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.

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXDOSFRMEXDOSFRQEXROUTEEXLOTEXRTVEXVAMTEXVAMTUEXSTDTCEXSTDY
1ABC-123EXABC-123-10011XYZ-1232.6mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-20T09:49:391
2ABC-123EXABC-123-10012XYZ-1232.6mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-21T09:36:082
3ABC-123EXABC-123-10013XYZ-1232.6mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-22T09:24:263
4ABC-123EXABC-123-10014XYZ-1232.7mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-23T09:55:144
5ABC-123EXABC-123-10015XYZ-1232.7mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-24T09:42:595
6ABC-123EXABC-123-10016XYZ-1232.7mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-25T09:15:166
7ABC-123EXABC-123-10017XYZ-1232.6mgSOLUTIONQDORAL GAVAGEXYZ123-01Saline5mL2017-06-26T09:08:407
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PC PP Cross-domain Example 1: PC

In this example, the applicant chose to populate PCTPTNUM with a value representing the number of hours postdose. The applicant populated PCCAT with ANALYTE and PCSCAT to differentiate between PARENT and METABOLITE.

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.

pc.xpt

pc.xpt

RowSTUDYIDDOMAINUSUBJIDPCSEQPCTESTCDPCTESTPCCATPCSCATPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCNAMPCSPECPCMETHODPCLLOQPCDTCPCDYPCNOMDYPCTPTPCTPTNUMPCELTMPCTPTREFPCRFTDTC
1ABC-123PCABC-123-10011XYZ123XYZ-123ANALYTEPARENT<LLOQng/mLBLQ
ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T09:49:0011Predose0PT0HDay 1 Dose2017-06-20T09:49:39
2ABC-123PCABC-123-10012XYZ123XYZ-123ANALYTEPARENT0.700ng/mL0.7000.7ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T10:04:00110.25 hour postdose0.25PT0.25HDay 1 Dose2017-06-20T09:49:39
3ABC-123PCABC-123-10013XYZ123XYZ-123ANALYTEPARENT8.1ng/mL8.18.1ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T10:19:00110.5 hour postdose0.5PT0.5HDay 1 Dose2017-06-20T09:49:39
4ABC-123PCABC-123-10014XYZ123XYZ-123ANALYTEPARENT44.0ng/mL44.044ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T10:44:00111 hour postdose1PT1HDay 1 Dose2017-06-20T09:49:39
5ABC-123PCABC-123-10015XYZ123XYZ-123ANALYTEPARENT108ng/mL108108ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T11:52:00112 hours postdose2PT2HDay 1 Dose2017-06-20T09:49:39
6ABC-123PCABC-123-10016XYZ123XYZ-123ANALYTEPARENT32.3ng/mL32.332.3ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T13:56:00114 hours postdose4PT4HDay 1 Dose2017-06-20T09:49:39
7ABC-123PCABC-123-10017XYZ123XYZ-123ANALYTEPARENT4.75ng/mL4.754.75ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T17:53:00118 hours postdose8PT8HDay 1 Dose2017-06-20T09:49:39
8ABC-123PCABC-123-10018XYZ123XYZ-123ANALYTEPARENT2.01ng/mL2.012.01ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T21:27:001112 hours postdose12PT12HDay 1 Dose2017-06-20T09:49:39
9ABC-123PCABC-123-10019XYZ123XYZ-123ANALYTEPARENT<LLOQng/mLBLQ
ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-21T09:53:002124 hours postdose24PT24HDay 1 Dose2017-06-20T09:49:39
10ABC-123PCABC-123-100110XYZ123XYZ-123ANALYTEPARENT<LLOQng/mLBLQ
ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T09:07:0077Predose0PT0HDay 7 Dose2017-06-26T09:08:40
11ABC-123PCABC-123-100111XYZ123XYZ-123ANALYTEPARENT7.69ng/mL7.697.69ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T09:23:00770.25 hour postdose0.25PT0.25HDay 7 Dose2017-06-26T09:08:40
12ABC-123PCABC-123-100112XYZ123XYZ-123ANALYTEPARENT39.8ng/mL39.839.8ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T09:37:00770.5 hour postdose0.5PT0.5HDay 7 Dose2017-06-26T09:08:40
13ABC-123PCABC-123-100113XYZ123XYZ-123ANALYTEPARENT140ng/mL140140ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T10:06:00771 hour postdose1PT1HDay 7 Dose2017-06-26T09:08:40
14ABC-123PCABC-123-100114XYZ123XYZ-123ANALYTEPARENT116ng/mL116116ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T10:56:00772 hours postdose2PT2HDay 7 Dose2017-06-26T09:08:40
15ABC-123PCABC-123-100115XYZ123XYZ-123ANALYTEPARENT52.2ng/mL52.252.2ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T13:08:00774 hours postdose4PT4HDay 7 Dose2017-06-26T09:08:40
16ABC-123PCABC-123-100116XYZ123XYZ-123ANALYTEPARENT18.3ng/mL18.318.3ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T17:07:00778 hours postdose8PT8HDay 7 Dose2017-06-26T09:08:40
17ABC-123PCABC-123-100117XYZ123XYZ-123ANALYTEPARENT14.4ng/mL14.414.4ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T21:26:007712 hours postdose12PT12HDay 7 Dose2017-06-26T09:08:40
18ABC-123PCABC-123-100118XYZ123XYZ-123ANALYTEPARENT2.01ng/mL2.012.01ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-27T08:13:008724 hours postdose24PT24HDay 7 Dose2017-06-26T09:08:40
19ABC-123PCABC-123-100119XYZ345XYZ-345ANALYTEMETABOLITE<LLOQng/mLBLQ
ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T09:49:0011Predose0PT0HDay 1 Dose2017-06-20T09:49:39
20ABC-123PCABC-123-100120XYZ345XYZ-345ANALYTEMETABOLITE<LLOQng/mLBLQ
ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T10:04:00110.25 hour postdose0.25PT0.25HDay 1 Dose2017-06-20T09:49:39
21ABC-123PCABC-123-100121XYZ345XYZ-345ANALYTEMETABOLITE11.6ng/mL11.611.6ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T10:19:00110.5 hour postdose0.5PT0.5HDay 1 Dose2017-06-20T09:49:39
22ABC-123PCABC-123-100122XYZ345XYZ-345ANALYTEMETABOLITE78.7ng/mL78.778.7ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T10:44:00111 hour postdose1PT1HDay 1 Dose2017-06-20T09:49:39
23ABC-123PCABC-123-100123XYZ345XYZ-345ANALYTEMETABOLITE699ng/mL699699ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T11:52:00112 hours postdose2PT2HDay 1 Dose2017-06-20T09:49:39
24ABC-123PCABC-123-100124XYZ345XYZ-345ANALYTEMETABOLITE205ng/mL205205ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T13:56:00114 hours postdose4PT4HDay 1 Dose2017-06-20T09:49:39
25ABC-123PCABC-123-100125XYZ345XYZ-345ANALYTEMETABOLITE21.8ng/mL21.821.8ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T17:53:00118 hours postdose8PT8HDay 1 Dose2017-06-20T09:49:39
26ABC-123PCABC-123-100126XYZ345XYZ-345ANALYTEMETABOLITE6.20ng/mL6.206.2ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-20T21:27:001112 hours postdose12PT12HDay 1 Dose2017-06-20T09:49:39
27ABC-123PCABC-123-100127XYZ345XYZ-345ANALYTEMETABOLITE1.66ng/mL1.661.66ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-21T09:53:002124 hours postdose24PT24HDay 1 Dose2017-06-20T09:49:39
28ABC-123PCABC-123-100128XYZ345XYZ-345ANALYTEMETABOLITE2.05ng/mL2.052.05ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T09:07:0077Predose0PT0HDay 7 Dose2017-06-26T09:08:40
29ABC-123PCABC-123-100129XYZ345XYZ-345ANALYTEMETABOLITE9.29ng/mL9.299.29ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T09:23:00770.25 hour postdose0.25PT0.25HDay 7 Dose2017-06-26T09:08:40
30ABC-123PCABC-123-100130XYZ345XYZ-345ANALYTEMETABOLITE39.8ng/mL39.839.8ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T09:37:00770.5 hour postdose0.5PT0.5HDay 7 Dose2017-06-26T09:08:40
31ABC-123PCABC-123-100131XYZ345XYZ-345ANALYTEMETABOLITE89.6ng/mL89.689.6ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T10:06:00771 hour postdose1PT1HDay 7 Dose2017-06-26T09:08:40
32ABC-123PCABC-123-100132XYZ345XYZ-345ANALYTEMETABOLITE92.8ng/mL92.892.8ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T10:56:00772 hours postdose2PT2HDay 7 Dose2017-06-26T09:08:40
33ABC-123PCABC-123-100133XYZ345XYZ-345ANALYTEMETABOLITE56.8ng/mL56.856.8ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T13:08:00774 hours postdose4PT4HDay 7 Dose2017-06-26T09:08:40
34ABC-123PCABC-123-100134XYZ345XYZ-345ANALYTEMETABOLITE15.2ng/mL15.215.2ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T17:07:00778 hours postdose8PT8HDay 7 Dose2017-06-26T09:08:40
35ABC-123PCABC-123-100135XYZ345XYZ-345ANALYTEMETABOLITE10.8ng/mL10.810.8ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-26T21:26:007712 hours postdose12PT12HDay 7 Dose2017-06-26T09:08:40
36ABC-123PCABC-123-100136XYZ345XYZ-345ANALYTEMETABOLITE3.66ng/mL3.663.66ng/mLBIOANALYSIS LAB XPLASMALC/MS/MS0.62017-06-27T08:13:008724 hours postdose24PT24HDay 7 Dose2017-06-26T09:08:40
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

pp.xpt

pp.xpt

RowSTUDYIDDOMAINUSUBJIDPPSEQPPTESTCDPPTESTPPCATPPSCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSTATPPREASNDPPSPECPPNOMDYPPTPTREFPPRFTDTCPPSTINTPPENINT
1ABC-123PPABC-123-10011TMAXTime of CMAXXYZ-123NON-COMPARTMENTAL2h22h

PLASMA1Day 1 Dose2017-06-20T09:49:39

2ABC-123PPABC-123-10012CMAXMax ConcXYZ-123NON-COMPARTMENTAL108ng/mL108108ng/mL

PLASMA1Day 1 Dose2017-06-20T09:49:39

3ABC-123PPABC-123-10013AUCLSTAUC to Last Nonzero ConcXYZ-123NON-COMPARTMENTAL318h*ng/mL318318h*ng/mL

PLASMA1Day 1 Dose2017-06-20T09:49:39

4ABC-123PPABC-123-10014TLSTTime of Last Nonzero ConcXYZ-123NON-COMPARTMENTAL12h1212h

PLASMA1Day 1 Dose2017-06-20T09:49:39

5ABC-123PPABC-123-10015AUCINTAUC from T1 to T2XYZ-123NON-COMPARTMENTAL330h*ng/mL330330h*ng/mL

PLASMA1Day 1 Dose2017-06-20T09:49:39PT0HPT24H
6ABC-123PPABC-123-10016TMAXTime of CMAXXYZ-123NON-COMPARTMENTAL1h11h

PLASMA7Day 7 Dose2017-06-26T09:08:40

7ABC-123PPABC-123-10017CMAXMax ConcXYZ-123NON-COMPARTMENTAL140ng/mL140140ng/mL

PLASMA7Day 7 Dose2017-06-26T09:08:40

8ABC-123PPABC-123-10018AUCLSTAUC to Last Nonzero ConcXYZ-123NON-COMPARTMENTAL653h*ng/mL653653h*ng/mL

PLASMA7Day 7 Dose2017-06-26T09:08:40

9ABC-123PPABC-123-10019TLSTTime of Last Nonzero ConcXYZ-123NON-COMPARTMENTAL24h2424h

PLASMA7Day 7 Dose2017-06-26T09:08:40

10ABC-123PPABC-123-100110AUCINTAUC from T1 to T2XYZ-123NON-COMPARTMENTAL653h*ng/mL653653h*ng/mL

PLASMA7Day 7 Dose2017-06-26T09:08:40PT0HPT24H
11ABC-123PPABC-123-100111ARCMAXAccumulation Ratio CmaxXYZ-123NON-COMPARTMENTAL1.30RATIO1.301.30RATIO

PLASMA7Day 7 Dose2017-06-26T09:08:40

12ABC-123PPABC-123-100112AUCLSTAUC to Last Nonzero ConcXYZ-345NON-COMPARTMENTAL1874h*ng/mL18741874h*ng/mL

PLASMA1Day 1 Dose2017-06-20T09:49:39

13ABC-123PPABC-123-100113TLSTTime of Last Nonzero ConcXYZ-345NON-COMPARTMENTAL24h2424h

PLASMA1Day 1 Dose2017-06-20T09:49:39

14ABC-123PPABC-123-100114AUCLSTAUC to Last Nonzero ConcXYZ-345NON-COMPARTMENTAL563h*ng/mL563563h*ng/mL

PLASMA7Day 7 Dose2017-06-26T09:08:40

15ABC-123PPABC-123-100115TLSTTime of Last Nonzero ConcXYZ-345NON-COMPARTMENTAL24h2424h

PLASMA7Day 7 Dose2017-06-26T09:08:40

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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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supppc.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1ABC-123PCABC-123-1001PCSTRESCBLQPCCALCNNumeric Interpretation for Calculations0DERIVED
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