Page History

Fill in results and units for rows 6 and 7
Fill in PKCOND values for rows 6 and 7
ANMETH is a "record qualifier" according to Model 2.0 so technically we don't need to add the METHOD variable into PP. There would only be one valid value of PPMETHOD anyway = CALCULATION. (Confirm with Fred)
- Rows 4-5 can the values in PPANMETH also in PPCAT? (Because PPCAT is blank)
- Should ANMETH be only used for named formulas like how LB is using it?
Remove PPMETHOD from PP specification table if decided not needed.
Review suppPP dataset makes sure it looks ok
Do people use PC/PP domain for compartmental analysis data as well? For CT we don’t control none-NCA values, but that’s CT ONLY, on the domain level, do people use PC/PP for None-NCA data anyway? The new term request from GSK asked for a controlled codelist for PKANMETH but the requested value is actually for compartmental analysis – this suggests to me that folks are using PC/PP for compartmental analysis data. Currently the SDTMIG does not explicitly state that users should only represent NCA data in PC/PP. Better understanding this would help to decide whether we should add ANMETH into PP.

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

...

Dataset wrap

Name	pp

Rowcaps

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

Metabolite 1 to Drug

Metabolite 1

Parent. Instead of

creating

pre-corrdinating "Ratio AUC of

Drug Parent over

Drug Metabolite 1 to Drug Parent"

in

all into the PPTEST,

the non-standard variable "NSV1 Name TBD"

PPANMETH is used to describe the numerator (Drug

Parent, PPSEQ

Metabolite 1) and the denominator (Drug

Metabolite 1, PPSEQ2

Parent) 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

Metabolite 2 to Drug Metabolite 1. Note the PPTEST is Ratio AUC, whereas DRUG METABOLITE 2 TO METABOLITE 1 is in PPANMETH.
Rows 6-7:	Show AUC Infinity Obs and AUC Infinity Pred for the DRUG PARENT. Both are calculated using the LIN-LOG TRAPEZOIDAL METHOD which is in PPANMETH.

Dataset2

CALCULATIONCALCULATIONMULTIPLE DOSE, STEADY STATECALCULATION

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			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			Y	1	2001-02-01T12:00
4	ABC-123	PP	123-1001	4	B2222	RAAUC	Ratio AUC	DRUG METABOLITE 1	NCA	1.07		1.07	1.07		PLASMA		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	DRUG METABOLITE 2	NCA	0.52		0.52	0.52		PLASMA	CALCULATION	DRUG METABOLITE 2 (PPSEQ 3) TO DRUG PARENT (PPSEQ 1)TO METABOLITE 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	520	h*ng/L	520	520	h*ng/L	PLASMACALCULATION	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	510	h*ng/L	510	510	PLASMA	h*ng/L	PLASMACALCULATION	LIN-LOG TRAPEZOIDAL METHOD	Y	1	2001-02-01T12:00

...

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

Dataset wrap

Name	supppp

Dataset2

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
6	ABC-123	PP	123-1001	PPSEQ	6	PKCOND	Condition of PK Analysis	MULTIPLE DOSE, STEADY STATE	eDT
7	ABC-123	PP	123-1001	PPSEQ	7	PKCOND	Condition of PK Analysis	SINGLE DOSE	eDT