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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.

Rows 1-4, 6-10, 12-19, 21-26:Show example concentration data and are provided for context.
Rows 13, 20:

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.

pc.xpt

pc.xpt

RowSTUDYIDDOMAINUSUBJIDPCSEQPCTESTCDPCTESTPCCATPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCSTATPCREASNDPCNAMPCSPECPCBLFLPCLLOQPCEXCLFLPCREASEXPCNOMDYPCDTCPCTPTPCTPTNUMPCELTMPCTPTREFPCRFTDTC
15311016PC5311016-1011A9876543ABC9876543PARENT3000ng/mL30003000ng/mL

ACME INCPLASMA
1

1
0H30MIN1PT30MDay 1 dose2018-01-01
25311016PC5311016-1013A9876543ABC9876543PARENT6240ng/mL62406240ng/mL

ACME INCPLASMA
1

1
1H2PT1HDay 1 dose2018-01-01
35311016PC5311016-1015A9876543ABC9876543PARENT6950ng/mL69506950ng/mL

ACME INCPLASMA
1

1
2H3PT2HDay 1 dose2018-01-01
45311016PC5311016-1017A9876543ABC9876543PARENT3630ng/mL36303630ng/mL

ACME INCPLASMA
1

1
4H4PT4HDay 1 dose2018-01-01
55311016PC5311016-1019A9876543ABC9876543PARENT
ng/mL

ng/mLNOT DONEMISSING SAMPLEACME INCPLASMA
1

1
8H5PT8HDay 1 dose2018-01-01
65311016PC5311016-10111A9876543ABC9876543PARENT27ng/mL2727ng/mL

ACME INCPLASMA
1

1
24H6PT24HDay 1 dose2018-01-01
75311016PC5311016-1012A9871234ABC9871234METABOLITE6680ng/mL66806680ng/mL

ACME INCPLASMA
1

1
0H30MIN1PT30MDay 1 dose2018-01-01
85311016PC5311016-1014A9871234ABC9871234METABOLITE11700ng/mL1170011700ng/mL

ACME INCPLASMA
1

1
1H2PT1HDay 1 dose2018-01-01
95311016PC5311016-1016A9871234ABC9871234METABOLITE14200ng/mL1420014200ng/mL

ACME INCPLASMA
1

1
2H3PT2HDay 1 dose2018-01-01
105311016PC5311016-1018A9871234ABC9871234METABOLITE13900ng/mL1390013900ng/mL

ACME INCPLASMA
1

1
4H4PT4HDay 1 dose2018-01-01
115311016PC5311016-10110A9871234ABC9871234METABOLITE
ng/mL

ng/mLNOT DONEMISSING SAMPLEACME INCPLASMA
1

1
8H5PT8HDay 1 dose2018-01-01
125311016PC5311016-10112A9871234ABC9871234METABOLITE90.1ng/mL90.190.1ng/mL

ACME INCPLASMA
1

1
24H6PT24HDay 1 dose2018-01-01
135311016PC5311016-10113A9876543ABC9876543PARENT<1ng/mLBLQ
ng/mL

ACME INCPLASMA
1

14
PREDOSE1PT0HDay 14 dose2018-01-14
145311016PC5311016-10115A9876543ABC9876543PARENT2970ng/mL29702970ng/mL

ACME INCPLASMA
1

14
0H30MIN2PT30MDay 14 dose2018-01-14
155311016PC5311016-10117A9876543ABC9876543PARENT6270ng/mL62706270ng/mL

ACME INCPLASMA
1

14
1H3PT1HDay 14 dose2018-01-14
165311016PC5311016-10119A9876543ABC9876543PARENT6290ng/mL62906290ng/mL

ACME INCPLASMA
1

14
2H4PT2HDay 14 dose2018-01-14
175311016PC5311016-10121A9876543ABC9876543PARENT3170ng/mL31703170ng/mL

ACME INCPLASMA
1

14
4H5PT4HDay 14 dose2018-01-14
185311016PC5311016-10123A9876543ABC9876543PARENT1550ng/mL15501550ng/mL

ACME INCPLASMA
1

14
8H6PT8HDay 14 dose2018-01-14

19

5311016PC5311016-10125A9876543ABC9876543PARENT49.5ng/mL49.549.5ng/mL

ACME INCPLASMA
1

14
24H7PT24HDay 14 dose2018-01-14
205311016PC5311016-10114A9871234ABC9871234METABOLITE<1ng/mLBLQ
ng/mL

ACME INCPLASMA
1

14
PREDOSE1PT0HDay 14 dose2018-01-14
215311016PC5311016-10116A9871234ABC9871234METABOLITE3350ng/mL33503350ng/mL

ACME INCPLASMA
1

14
0H30MIN2PT30MDay 14 dose2018-01-14
225311016PC5311016-10118A9871234ABC9871234METABOLITE8370ng/mL83708370ng/mL

ACME INCPLASMA
1

14
1H3PT1HDay 14 dose2018-01-14
235311016PC5311016-10120A9871234ABC9871234METABOLITE14800ng/mL1480014800ng/mL

ACME INCPLASMA
1

14
2H4PT2HDay 14 dose2018-01-14
245311016PC5311016-10122A9871234ABC9871234METABOLITE11900ng/mL1190011900ng/mL

ACME INCPLASMA
1

14
4H5PT4HDay 14 dose2018-01-14
255311016PC5311016-10124A9871234ABC9871234METABOLITE8610ng/mL86108610ng/mL

ACME INCPLASMA
1

14
8H6PT8HDay 14 dose2018-01-14
265311016PC5311016-10126A9871234ABC9871234METABOLITE124ng/mL124124ng/mL

ACME INCPLASMA
1YConcentration result excluded due to hemolysis14
24H7PT24HDay 14 dose2018-01-14
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

pp.xpt

pp.xpt

RowSTUDYIDDOMAINUSUBJIDPPSEQPPTESTCDPPTESTPPCATPPSCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSPECPPNOMDYPPTPTREFPPRFTDTCPPSTINTPPENINT
15311016PP5311016-1011AUCINTAUC from T1 to T2ABC9876543PARENT56805h*ng/mL5680556805h*ng/mLPLASMA1Day 1 dose2018-01-01PT0HPT24H
25311016PP5311016-1012CMAXMax ConcABC9876543PARENT6950ng/mL69506950ng/mLPLASMA1Day 1 dose2018-01-01

35311016PP5311016-1013TMAXMax ConcABC9876543PARENT2h22hPLASMA1Day 1 dose2018-01-01

45311016PP5311016-1014AUCINTDAUC from T1 to T2 Norm by DoseABC9876543PARENT5681h*ng/mL/(mg/kg)56815681h*ng/mL/(mg/kg)PLASMA1Day 1 dose2018-01-01PT0HPT24H
55311016PP5311016-1015CMAXDMax Conc Norm by DoseABC9876543PARENT695ng/mL/(mg/kg)695695ng/mL/(mg/kg)PLASMA1Day 1 dose2018-01-01

65311016PP5311016-1016AUCINTAUC from T1 to T2ABC9876543PARENT41029h*ng/mL4102941029h*ng/mLPLASMA14Day 14 dose2018-01-01PT0HPT24H
75311016PP5311016-1017CMAXMax ConcABC9876543PARENT6290ng/mL62906290ng/mLPLASMA14Day 14 dose2018-01-01

85311016PP5311016-1018TMAXTime of CMAXABC9876543PARENT2h22hPLASMA14Day 14 dose2018-01-01

95311016PP5311016-1019AUCINTDAUC from T1 to T2 Norm by DoseABC9876543PARENT4103h*ng/mL/(mg/kg)41034103h*ng/mL/(mg/kg)PLASMA14Day 14 dose2018-01-01PT0HPT24H
105311016PP5311016-10110CMAXDMax Conc Norm by DoseABC9876543PARENT629ng/mL/(mg/kg)629629ng/mL/(mg/kg)PLASMA14Day 14 dose2018-01-01

115311016PP5311016-10111AUCINTAUC from T1 to T2ABC9871234METABOLITE187216h*ng/mL187216187216h*ng/mLPLASMA1Day 1 dose2018-01-01PT0HPT24H
125311016PP5311016-10112CMAXMax ConcABC9871234METABOLITE14200ng/mL1420014200ng/mLPLASMA1Day 1 dose2018-01-01

135311016PP5311016-10113TMAXTime of CMAXABC9871234METABOLITE2h22hPLASMA1Day 1 dose2018-01-14

145311016PP5311016-10114AUCINTDAUC from T1 to T2 Norm by DoseABC9871234METABOLITE18722h*ng/mL/(mg/kg)1872218722h*ng/mL/(mg/kg)PLASMA1Day 1 dose2018-01-14PT0HPT24H
155311016PP5311016-10115CMAXDMax Conc Norm by DoseABC9871234METABOLITE1420ng/mL/(mg/kg)14201420ng/mL/(mg/kg)PLASMA1Day 1 dose2018-01-14

165311016PP5311016-10116AUCINTAUC from T1 to T2ABC9871234METABOLITE152945h*ng/mL152945152945h*ng/mLPLASMA14Day 14 dose2018-01-14PT0HPT24H
175311016PP5311016-10117CMAXMax ConcABC9871234METABOLITE14800ng/mL1480014800ng/mLPLASMA14Day 14 dose2018-01-14

185311016PP5311016-10118TMAXTime of CMAXABC9871234METABOLITE2h22hPLASMA14Day 14 dose2018-01-14

195311016PP5311016-10119AUCINTDAUC from T1 to T2 Norm by DoseABC9871234METABOLITE15295h*ng/mL/(mg/kg)1529515295h*ng/mL/(mg/kg)PLASMA14Day 14 dose2018-01-14PT0HPT24H
205311016PP5311016-10120CMAXDMax Conc Norm by DoseABC9871234METABOLITE1480ng/mL/(mg/kg)14801480ng/mL/(mg/kg)PLASMA14Day 14 dose2018-01-14
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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.

$titleHtml

supppc.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
15311016PC5311016-101PCSTRESCBLQPCCALCNNumeric Interpretation for Calculations0DERIVED
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