PC PP Multi-domain Example 1

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

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EXLOT	EXRTV	EXVAMT	EXVAMTU	EXSTDTC	EXSTDY
1	ABC-123	EX	ABC-123-1001	1	XYZ-123	2.6	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-20T09:49:39	1
2	ABC-123	EX	ABC-123-1001	2	XYZ-123	2.6	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-21T09:36:08	2
3	ABC-123	EX	ABC-123-1001	3	XYZ-123	2.6	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-22T09:24:26	3
4	ABC-123	EX	ABC-123-1001	4	XYZ-123	2.7	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-23T09:55:14	4
5	ABC-123	EX	ABC-123-1001	5	XYZ-123	2.7	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-24T09:42:59	5
6	ABC-123	EX	ABC-123-1001	6	XYZ-123	2.7	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-25T09:15:16	6
7	ABC-123	EX	ABC-123-1001	7	XYZ-123	2.6	mg	SOLUTION	QD	ORAL GAVAGE	XYZ123-01	Saline	5	mL	2017-06-26T09:08:40	7

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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

Row	STUDYID	DOMAIN	USUBJID	PCSEQ	PCTESTCD	PCTEST	PCCAT	PCSCAT	PCORRES	PCORRESU	PCSTRESC	PCSTRESN	PCSTRESU	PCNAM	PCSPEC	PCMETHOD	PCLLOQ	PCDTC	PCDY	PCNOMDY	PCTPT	PCTPTNUM	PCELTM	PCTPTREF	PCRFTDTC
1	ABC-123	PC	ABC-123-1001	1	XYZ123	XYZ-123	ANALYTE	PARENT	<LLOQ	ng/mL	BLQ		ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T09:49:00	1	1	Predose	0	PT0H	Day 1 Dose	2017-06-20T09:49:39
2	ABC-123	PC	ABC-123-1001	2	XYZ123	XYZ-123	ANALYTE	PARENT	0.700	ng/mL	0.700	0.7	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T10:04:00	1	1	0.25 hour postdose	0.25	PT0.25H	Day 1 Dose	2017-06-20T09:49:39
3	ABC-123	PC	ABC-123-1001	3	XYZ123	XYZ-123	ANALYTE	PARENT	8.1	ng/mL	8.1	8.1	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T10:19:00	1	1	0.5 hour postdose	0.5	PT0.5H	Day 1 Dose	2017-06-20T09:49:39
4	ABC-123	PC	ABC-123-1001	4	XYZ123	XYZ-123	ANALYTE	PARENT	44.0	ng/mL	44.0	44	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T10:44:00	1	1	1 hour postdose	1	PT1H	Day 1 Dose	2017-06-20T09:49:39
5	ABC-123	PC	ABC-123-1001	5	XYZ123	XYZ-123	ANALYTE	PARENT	108	ng/mL	108	108	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T11:52:00	1	1	2 hours postdose	2	PT2H	Day 1 Dose	2017-06-20T09:49:39
6	ABC-123	PC	ABC-123-1001	6	XYZ123	XYZ-123	ANALYTE	PARENT	32.3	ng/mL	32.3	32.3	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T13:56:00	1	1	4 hours postdose	4	PT4H	Day 1 Dose	2017-06-20T09:49:39
7	ABC-123	PC	ABC-123-1001	7	XYZ123	XYZ-123	ANALYTE	PARENT	4.75	ng/mL	4.75	4.75	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T17:53:00	1	1	8 hours postdose	8	PT8H	Day 1 Dose	2017-06-20T09:49:39
8	ABC-123	PC	ABC-123-1001	8	XYZ123	XYZ-123	ANALYTE	PARENT	2.01	ng/mL	2.01	2.01	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T21:27:00	1	1	12 hours postdose	12	PT12H	Day 1 Dose	2017-06-20T09:49:39
9	ABC-123	PC	ABC-123-1001	9	XYZ123	XYZ-123	ANALYTE	PARENT	<LLOQ	ng/mL	BLQ		ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-21T09:53:00	2	1	24 hours postdose	24	PT24H	Day 1 Dose	2017-06-20T09:49:39
10	ABC-123	PC	ABC-123-1001	10	XYZ123	XYZ-123	ANALYTE	PARENT	<LLOQ	ng/mL	BLQ		ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T09:07:00	7	7	Predose	0	PT0H	Day 7 Dose	2017-06-26T09:08:40
11	ABC-123	PC	ABC-123-1001	11	XYZ123	XYZ-123	ANALYTE	PARENT	7.69	ng/mL	7.69	7.69	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T09:23:00	7	7	0.25 hour postdose	0.25	PT0.25H	Day 7 Dose	2017-06-26T09:08:40
12	ABC-123	PC	ABC-123-1001	12	XYZ123	XYZ-123	ANALYTE	PARENT	39.8	ng/mL	39.8	39.8	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T09:37:00	7	7	0.5 hour postdose	0.5	PT0.5H	Day 7 Dose	2017-06-26T09:08:40
13	ABC-123	PC	ABC-123-1001	13	XYZ123	XYZ-123	ANALYTE	PARENT	140	ng/mL	140	140	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T10:06:00	7	7	1 hour postdose	1	PT1H	Day 7 Dose	2017-06-26T09:08:40
14	ABC-123	PC	ABC-123-1001	14	XYZ123	XYZ-123	ANALYTE	PARENT	116	ng/mL	116	116	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T10:56:00	7	7	2 hours postdose	2	PT2H	Day 7 Dose	2017-06-26T09:08:40
15	ABC-123	PC	ABC-123-1001	15	XYZ123	XYZ-123	ANALYTE	PARENT	52.2	ng/mL	52.2	52.2	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T13:08:00	7	7	4 hours postdose	4	PT4H	Day 7 Dose	2017-06-26T09:08:40
16	ABC-123	PC	ABC-123-1001	16	XYZ123	XYZ-123	ANALYTE	PARENT	18.3	ng/mL	18.3	18.3	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T17:07:00	7	7	8 hours postdose	8	PT8H	Day 7 Dose	2017-06-26T09:08:40
17	ABC-123	PC	ABC-123-1001	17	XYZ123	XYZ-123	ANALYTE	PARENT	14.4	ng/mL	14.4	14.4	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T21:26:00	7	7	12 hours postdose	12	PT12H	Day 7 Dose	2017-06-26T09:08:40
18	ABC-123	PC	ABC-123-1001	18	XYZ123	XYZ-123	ANALYTE	PARENT	2.01	ng/mL	2.01	2.01	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-27T08:13:00	8	7	24 hours postdose	24	PT24H	Day 7 Dose	2017-06-26T09:08:40
19	ABC-123	PC	ABC-123-1001	19	XYZ345	XYZ-345	ANALYTE	METABOLITE	<LLOQ	ng/mL	BLQ		ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T09:49:00	1	1	Predose	0	PT0H	Day 1 Dose	2017-06-20T09:49:39
20	ABC-123	PC	ABC-123-1001	20	XYZ345	XYZ-345	ANALYTE	METABOLITE	<LLOQ	ng/mL	BLQ		ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T10:04:00	1	1	0.25 hour postdose	0.25	PT0.25H	Day 1 Dose	2017-06-20T09:49:39
21	ABC-123	PC	ABC-123-1001	21	XYZ345	XYZ-345	ANALYTE	METABOLITE	11.6	ng/mL	11.6	11.6	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T10:19:00	1	1	0.5 hour postdose	0.5	PT0.5H	Day 1 Dose	2017-06-20T09:49:39
22	ABC-123	PC	ABC-123-1001	22	XYZ345	XYZ-345	ANALYTE	METABOLITE	78.7	ng/mL	78.7	78.7	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T10:44:00	1	1	1 hour postdose	1	PT1H	Day 1 Dose	2017-06-20T09:49:39
23	ABC-123	PC	ABC-123-1001	23	XYZ345	XYZ-345	ANALYTE	METABOLITE	699	ng/mL	699	699	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T11:52:00	1	1	2 hours postdose	2	PT2H	Day 1 Dose	2017-06-20T09:49:39
24	ABC-123	PC	ABC-123-1001	24	XYZ345	XYZ-345	ANALYTE	METABOLITE	205	ng/mL	205	205	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T13:56:00	1	1	4 hours postdose	4	PT4H	Day 1 Dose	2017-06-20T09:49:39
25	ABC-123	PC	ABC-123-1001	25	XYZ345	XYZ-345	ANALYTE	METABOLITE	21.8	ng/mL	21.8	21.8	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T17:53:00	1	1	8 hours postdose	8	PT8H	Day 1 Dose	2017-06-20T09:49:39
26	ABC-123	PC	ABC-123-1001	26	XYZ345	XYZ-345	ANALYTE	METABOLITE	6.20	ng/mL	6.20	6.2	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-20T21:27:00	1	1	12 hours postdose	12	PT12H	Day 1 Dose	2017-06-20T09:49:39
27	ABC-123	PC	ABC-123-1001	27	XYZ345	XYZ-345	ANALYTE	METABOLITE	1.66	ng/mL	1.66	1.66	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-21T09:53:00	2	1	24 hours postdose	24	PT24H	Day 1 Dose	2017-06-20T09:49:39
28	ABC-123	PC	ABC-123-1001	28	XYZ345	XYZ-345	ANALYTE	METABOLITE	2.05	ng/mL	2.05	2.05	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T09:07:00	7	7	Predose	0	PT0H	Day 7 Dose	2017-06-26T09:08:40
29	ABC-123	PC	ABC-123-1001	29	XYZ345	XYZ-345	ANALYTE	METABOLITE	9.29	ng/mL	9.29	9.29	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T09:23:00	7	7	0.25 hour postdose	0.25	PT0.25H	Day 7 Dose	2017-06-26T09:08:40
30	ABC-123	PC	ABC-123-1001	30	XYZ345	XYZ-345	ANALYTE	METABOLITE	39.8	ng/mL	39.8	39.8	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T09:37:00	7	7	0.5 hour postdose	0.5	PT0.5H	Day 7 Dose	2017-06-26T09:08:40
31	ABC-123	PC	ABC-123-1001	31	XYZ345	XYZ-345	ANALYTE	METABOLITE	89.6	ng/mL	89.6	89.6	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T10:06:00	7	7	1 hour postdose	1	PT1H	Day 7 Dose	2017-06-26T09:08:40
32	ABC-123	PC	ABC-123-1001	32	XYZ345	XYZ-345	ANALYTE	METABOLITE	92.8	ng/mL	92.8	92.8	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T10:56:00	7	7	2 hours postdose	2	PT2H	Day 7 Dose	2017-06-26T09:08:40
33	ABC-123	PC	ABC-123-1001	33	XYZ345	XYZ-345	ANALYTE	METABOLITE	56.8	ng/mL	56.8	56.8	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T13:08:00	7	7	4 hours postdose	4	PT4H	Day 7 Dose	2017-06-26T09:08:40
34	ABC-123	PC	ABC-123-1001	34	XYZ345	XYZ-345	ANALYTE	METABOLITE	15.2	ng/mL	15.2	15.2	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T17:07:00	7	7	8 hours postdose	8	PT8H	Day 7 Dose	2017-06-26T09:08:40
35	ABC-123	PC	ABC-123-1001	35	XYZ345	XYZ-345	ANALYTE	METABOLITE	10.8	ng/mL	10.8	10.8	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-26T21:26:00	7	7	12 hours postdose	12	PT12H	Day 7 Dose	2017-06-26T09:08:40
36	ABC-123	PC	ABC-123-1001	36	XYZ345	XYZ-345	ANALYTE	METABOLITE	3.66	ng/mL	3.66	3.66	ng/mL	BIOANALYSIS LAB X	PLASMA	LC/MS/MS	0.6	2017-06-27T08:13:00	8	7	24 hours postdose	24	PT24H	Day 7 Dose	2017-06-26T09:08:40

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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

Row	STUDYID	DOMAIN	USUBJID	PPSEQ	PPTESTCD	PPTEST	PPCAT	PPSCAT	PPORRES	PPORRESU	PPSTRESC	PPSTRESN	PPSTRESU	PPSPEC	PPNOMDY	PPTPTREF	PPRFTDTC	PPSTINT	PPENINT
1	ABC-123	PP	ABC-123-1001	1	TMAX	Time of CMAX	XYZ-123	NON-COMPARTMENTAL	2	h	2	2	h	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39
2	ABC-123	PP	ABC-123-1001	2	CMAX	Max Conc	XYZ-123	NON-COMPARTMENTAL	108	ng/mL	108	108	ng/mL	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39
3	ABC-123	PP	ABC-123-1001	3	AUCLST	AUC to Last Nonzero Conc	XYZ-123	NON-COMPARTMENTAL	318	h*ng/mL	318	318	h*ng/mL	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39
4	ABC-123	PP	ABC-123-1001	4	TLST	Time of Last Nonzero Conc	XYZ-123	NON-COMPARTMENTAL	12	h	12	12	h	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39
5	ABC-123	PP	ABC-123-1001	5	AUCINT	AUC from T1 to T2	XYZ-123	NON-COMPARTMENTAL	330	h*ng/mL	330	330	h*ng/mL	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39	PT0H	PT24H
6	ABC-123	PP	ABC-123-1001	6	TMAX	Time of CMAX	XYZ-123	NON-COMPARTMENTAL	1	h	1	1	h	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40
7	ABC-123	PP	ABC-123-1001	7	CMAX	Max Conc	XYZ-123	NON-COMPARTMENTAL	140	ng/mL	140	140	ng/mL	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40
8	ABC-123	PP	ABC-123-1001	8	AUCLST	AUC to Last Nonzero Conc	XYZ-123	NON-COMPARTMENTAL	653	h*ng/mL	653	653	h*ng/mL	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40
9	ABC-123	PP	ABC-123-1001	9	TLST	Time of Last Nonzero Conc	XYZ-123	NON-COMPARTMENTAL	24	h	24	24	h	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40
10	ABC-123	PP	ABC-123-1001	10	AUCINT	AUC from T1 to T2	XYZ-123	NON-COMPARTMENTAL	653	h*ng/mL	653	653	h*ng/mL	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40	PT0H	PT24H
11	ABC-123	PP	ABC-123-1001	11	ARCMAX	Accumulation Ratio Cmax	XYZ-123	NON-COMPARTMENTAL	1.30	RATIO	1.30	1.30	RATIO	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40
12	ABC-123	PP	ABC-123-1001	12	AUCLST	AUC to Last Nonzero Conc	XYZ-345	NON-COMPARTMENTAL	1874	h*ng/mL	1874	1874	h*ng/mL	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39
13	ABC-123	PP	ABC-123-1001	13	TLST	Time of Last Nonzero Conc	XYZ-345	NON-COMPARTMENTAL	24	h	24	24	h	PLASMA	1	Day 1 Dose	2017-06-20T09:49:39
14	ABC-123	PP	ABC-123-1001	14	AUCLST	AUC to Last Nonzero Conc	XYZ-345	NON-COMPARTMENTAL	563	h*ng/mL	563	563	h*ng/mL	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40
15	ABC-123	PP	ABC-123-1001	15	TLST	Time of Last Nonzero Conc	XYZ-345	NON-COMPARTMENTAL	24	h	24	24	h	PLASMA	7	Day 7 Dose	2017-06-26T09:08:40

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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

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	ABC-123	PC	ABC-123-1001	PCSTRESC	BLQ	PCCALCN	Numeric Interpretation for Calculations	0	DERIVED

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