PP Domain New Variables Proposal Working Page

The example below shows how to represent various PK analysis parameters at multiple dose, steady state condition.

Rows 1-3:	Show the "AUC from T1 to T2" measurements for Drug Parent (Row 1), Drug Metabolite 1 (Row 2) and Drug Metabolite 2 (Row 3).
Row 4:	Shows the "Ratio AUC" measurement of Drug Parent to Drug Metabolite 1. Instead of creating "Ratio AUC of Drug Parent over Drug Metabolite 1" in the PPTEST, the non-standard variable "NSV1 Name TBD" is used to describe the numerator (Drug Parent, PPSEQ 1) and the denominator (Drug Metabolite 1, PPSEQ2) values that contribute to the Ratio AUC calculation in PPTEST. This post-coordination approach liberates the PPTEST variable from having to house hyper-specific, pre-coordinated PK parameter values.
Row 5:	Shows the "Ratio AUC" measurement of Drug Parent over Drug Metabolite 2.

pp.xpt

Row	STUDYID	DOMAIN	USUBJID	PPSEQ	PPRFID	PPTESTCD	PPTEST	PPCAT	PPSCAT	PPORRES	PPORRESU	PPSTRESC	PPSTRESN	PPSTRESU	PPSPEC	PPMETHOD	PPANMETH	PPFAST	PPNOMDY	PPRFTDTC	PKCOND
1	ABC-123	PP	123-1001	1	B2222	AUCINT	AUC from T1 to T2	DRUG PARENT	NCA	154.1	h*ng/L	154.1	154.1	h*ng/L	PLASMA	CALCULATION		Y	1	2001-02-01T12:00	MULTIPLE DOSE, STEADY STATE
2	ABC-123	PP	123-1001	2	B2222	AUCINT	AUC from T1 to T2	DRUG METABOLITE 1	NCA	144.5	h*ng/L	144.5	144.5	h*ng/L	PLASMA	CALCULATION		Y	1	2001-02-01T12:00	MULTIPLE DOSE, STEADY STATE
3	ABC-123	PP	123-1001	3	B2222	AUCINT	AUC from T1 to T2	DRUG METABOLITE 2	NCA	294.7	h*ng/L	294.7	294.7	h*ng/L	PLASMA	CALCULATION		Y	1	2001-02-01T12:00	MULTIPLE DOSE, STEADY STATE
4	ABC-123	PP	123-1001	4	B2222	RAAUC	Ratio AUC		NCA	1.07		1.07	1.07		PLASMA	CALCULATION	DRUG METABOLITE 1 (PPSEQ 2) TO DRUG PARENT (PPSEQ 1)	Y	1	2001-02-01T12:00	MULTIPLE DOSE, STEADY STATE
5	ABC-123	PP	123-1001	5	B2222	RAAUC	Ratio AUC		NCA	0.52		0.52	0.52		PLASMA	CALCULATION	DRUG METABOLITE 2 (PPSEQ 3) TO DRUG PARENT (PPSEQ 1)	Y	1	2001-02-01T12:00	MULTIPLE DOSE, STEADY STATE
6	ABC-123	PP	123-1001	1	B2222	AUCIFO	AUC Infinity Obs	DRUG PARENT	NCA						PLASMA	CALCULATION	LIN-LOG TRAPEZOIDAL METHOD	Y	1	2001-02-01T12:00
7	ABC-123	PP	123-1001	2	B2222	AUCIFP	AUC Infinity Pred	DRUG PARENT	NCA						PLASMA	CALCULATION	LIN-LOG TRAPEZOIDAL METHOD	Y	1	2001-02-01T12:00

Dataset Debug Messages

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The SUPPPP dataset example shows the condition under which the PK Analyais was performed.

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supppp.xpt

Row	STUDYID	DOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	ABC-123	PP	123-1001	PPSEQ	1	PKCOND	Condition of PK Analysis	MULTIPLE DOSE, STEADY STATE	eDT
2	ABC-123	PP	123-1001	PPSEQ	2	PKCOND	Condition of PK Analysis	MULTIPLE DOSE, STEADY STATE	eDT
3	ABC-123	PP	123-1001	PPSEQ	3	PKCOND	Condition of PK Analysis	MULTIPLE DOSE, STEADY STATE	eDT
4	ABC-123	PP	123-1001	PPSEQ	4	PKCOND	Condition of PK Analysis	MULTIPLE DOSE, STEADY STATE	eDT
5	ABC-123	PP	123-1001	PPSEQ	5	PKCOND	Condition of PK Analysis	MULTIPLE DOSE, STEADY STATE	eDT
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Dataset Debug Message

There seem to be multiple domains (PP, <br/>) present in the dataset.