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.
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 pre-corrdinating "Ratio AUC of Drug Parent over Drug Metabolite 1" all into the PPTEST, PPANMETH 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 to Drug Metabolite 2. Instead of pre-corrdinating "Ratio AUC of Drug Parent over Drug Metabolite 2" all into the PPTEST, PPANMETH is used to describe the numerator (Drug Parent, PPSEQ 1) and the denominator (Drug Metabolite 2, PPSEQ3) 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.
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.
pp.xpt
pp.xpt
Row
STUDYID
DOMAIN
USUBJID
PPSEQ
PPRFID
PPTESTCD
PPTEST
PPCAT
PPSCAT
PPORRES
PPORRESU
PPSTRESC
PPSTRESN
PPSTRESU
PPSPEC
PPANMETH
PPFAST
PPNOMDY
PPRFTDTC
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
Y
1
2001-02-01T12:00
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
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 TO DRUG PARENT
Y
1
2001-02-01T12:00
5
ABC-123
PP
123-1001
5
B2222
RAAUC
Ratio AUC
DRUG METABOLITE 2
NCA
0.52
0.52
0.52
PLASMA
DRUG METABOLITE 2 TO METABOLITE 1
Y
1
2001-02-01T12:00
6
ABC-123
PP
123-1001
1
B2222
AUCIFO
AUC Infinity Obs
DRUG PARENT
NCA
520
h*ng/L
520
520
h*ng/L
PLASMA
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
h*ng/L
PLASMA
LIN-LOG TRAPEZOIDAL METHOD
Y
1
2001-02-01T12:00
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The SUPPPP dataset example shows the specific condition under which the PK Analysis was performed.