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
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)