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
PPMETHOD
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
CALCULATION
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
CALCULATION
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
CALCULATION
Y
1
2001-02-01T12:00
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
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
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 Message
Please remove all paragraph and/or line breaks.
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.
$titleHtml
supppp.xpt
Row
STUDYID
DOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
QEVAL
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
7
Dataset Debug Message
There seem to be multiple domains (PP, <br/>) present in the dataset.