PC PP Multi-domain Example 3

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

Row	STUDYID	DOMAIN	USUBJID	PCSEQ	PCTESTCD	PCTEST	PCORRES	PCORRESU	PCSTRESC	PCSTRESN	PCSTRESU	PCNAM	PCSPEC	PCMETHOD	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

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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

Row	STUDYID	DOMAIN	POOLID	PPSEQ	PPTESTCD	PPTEST	PPCAT	PPORRES	PPORRESU	PPSTRESC	PPSTRESN	PPSTRESU	PPSTAT	PPREASND	PPSPEC	PPNOMDY	PPTPTREF
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

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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

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QORIG
1	ABC-123	PC	ABC-123-2007	PCSTRESC	BLQ	PCCALCN	Numeric Interpretation for Calculations	DERIVED
2	ABC-123	PC	ABC-123-2008	PCSTRESC	BLQ	PCCALCN	Numeric Interpretation for Calculations	DERIVED
3	ABC-123	PC	ABC-123-2009	PCSTRESC	BLQ	PCCALCN	Numeric Interpretation for Calculations	DERIVED

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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

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

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PC PP Multi-domain Example 3