Pharmacokinetics Parameters (PP)

Example

This example illustrates several tests for area under the curve, demonstrating the different ways of qualifying these tests. This study had a dosing interval of 24 hours, last dose on day 28, and TK sampling until at least 72 hours.

Rows 1, 4-5:	AUCINT is qualified by the planned elapsed time from dosing to the start and the end of the interval using the specific planned elapsed time variables for intervals: PPSTINT and PPENINT.
Rows 2, 6:	AUCLST is the area under the curve from time of dose to the last measurable concentration.
Rows 3, 7:	TLST is the observed time of the last measurable concentration. This parameter was included because it qualifies the AUCLST.

pp.xpt

Row	STUDYID	DOMAIN	USUBJID	PPSEQ	PPTESTCD	PPTEST	PPCAT	PPORRES	PPORRESU	PPSTRESC	PPSTRESN	PPSTRESU	PPSPEC	PPNOMLBL	PPTPTREF	PPRFTDTC	PPSTINT	PPENINT
1	ABC-123	PP	ABC-123-1001	1	AUCINT	AUC from T1 to T2	XYZ-123	271	h*ng/mL	271	271	h*ng/mL	PLASMA	1	Day 1 Dose	2018-01-01T09:50:36	PT0H	PT24H
2	ABC-123	PP	ABC-123-1001	2	AUCLST	AUC to Last Nonzero Conc	XYZ-123	271	h*ng/mL	271	271	h*ng/mL	PLASMA	1	Day 1 Dose	2018-01-01T09:50:36
3	ABC-123	PP	ABC-123-1001	3	TLST	Time of Last Nonzero Conc	XYZ-123	24	h	24	24	h	PLASMA	1	Day 1 Dose	2018-01-01T09:50:36
4	ABC-123	PP	ABC-123-1001	4	AUCINT	AUC from T1 to T2	XYZ-123	270	h*ng/mL	270	270	h*ng/mL	PLASMA	28	Day 28 Dose	2018-01-28T09:55:14	PT0H	PT24H
5	ABC-123	PP	ABC-123-1001	5	AUCINT	AUC from T1 to T2	XYZ-123	324	h*ng/mL	324	324	h*ng/mL	PLASMA	28	Day 28 Dose	2018-01-28T09:55:14	PT0H	PT72H
6	ABC-123	PP	ABC-123-1001	6	AUCLST	AUC to Last Nonzero Conc	XYZ-123	324	h*ng/mL	324	324	h*ng/mL	PLASMA	28	Day 28 Dose	2018-01-28T09:55:14
7	ABC-123	PP	ABC-123-1001	7	TLST	Time of Last Nonzero Conc	XYZ-123	72	h	72	72	h	PLASMA	28	Day 28 Dose	2018-01-28T09:55:14

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