This example shows PK parameters calculated from time-concentration profiles for the nicotine for one subject at Day 1. Typically, the same PK parameters would be provided for cotinine, and NNN but are only shown for TMAX. Note that PPRFTDTC is populated in order to link the PP records to the respective PC records.
Other parameters may be calculated but are not shown. They may include 1- R2. R Squared; 2- R2ADJ R Squared Adjusted 3. AUCIFO, AUC Infinity Obs, 4. AUCPEO, AUC %Extrapolation Obs 5- AUCTAU ,AUC Over Dosing Interval 6-LAMZNPT Number of Points for Lambda z 7- ,LAMZUL, Lambda z Upper Limit 8.LAMZLL Lambda z Lower Limit. These PP parameters are included in the Controlled terminology..
Rows 1-2:
Show parameters TMAX and CMAX for day 1.
Rows 13-24:
Show parameters AUC for Day 1. Note AUCALL was calculated as AUC from 0- to the last value and AUCINT was calculated as 0 to10 minutes. This interval is represented in PPSTINI, and PPENINT.
pp.xpt
pp.xpt
Row
STUDYID
DOMAIN
USUBJID
PPSEQ
PPGRPID
PPTESTCD
PPTEST
PPCAT
PPORRES
PPORRESU
PPSTRESC
PPSTRESN
PPSTRESU
PPSPEC
PPANMETH
VISITNUM
VISIT
PPDTC
PPRFTDTC
PPSTINT
PPENINT
1
ABC-123
PP
123-0001
1
DAY1_PAR
TMAX
Time of CMAX
NICOTINE
5
m
5
5
m
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2002-01-07
2001-02-01T08:00
2
ABC-123
PP
123-0001
2
DAY1_PAR
CMAX
Max Conc
NICOTINE
13
ng/mL
13
13
ng/mL
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2002-01-07
2001-02-01T08:00
3
ABC-123
PP
123-0001
3
DAY1_PAR
AUCALL
AUC All
NICOTINE
11.4
h*ng/mL
11.4
11.4
h*ng/mL
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2002-01-07
2001-02-01T08:00
3
ABC-123
PP
123-0001
4
DAY1_PAR
AUCINT
AUC from T1 to T2
NICOTINE
6.0
h*ng/mL
6.0
6.0
h*ng/mL
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2002-01-07
2001-02-01T08:00
0
10
4
ABC-123
PP
123-0001
5
TMAX
Time of CMAX
COTININE
6
m
6
6
m
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2002-01-07
2001-02-01T08:00
5
ABC-123
PP
123-0001
6
TMAX
Time of CMAX
NNN
7
m
7
7
m
PLASMA
non-compartmental analysis. and corrected for baseline