The Pharmacokinetics Concentrations (PC)) and Pharmacokinetics Parameters (PP) domains are based on the Findings General Observation class. The (PC domain is used to represent concentrations of drugs or metabolites in fluids or tissues as a function of time. The PP domain is used to represent pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. PP is a derived dataset.
Measuring nicotine blood concentration profile after a subject is exposed to a tobacco product is a widely-used method to quantify exposure.
Example
This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine. Two different nicotine products were used in the study. Each product was evaluated in a 180-minute test session with 1-3 days in between each product use. Plasma samples were taken at 45, 30, and 15 minutes prior to the start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, and 120 minutes after the start of product use. (More time points are often used; these timepoints presented were used only for illustration to save space.)
The PCLLOQ for the analytes measured were reported; PCULOQs were not reported.
Rows 1-3:
Show the day 1 pre-dose concentrations of nicotine in plasma at 45, 30 and 15 min before start of delivery of the nicotine. PCDTC is populated to indicate when these specimens were collected.
Rows 4-8:
Show the day 1 concentrations of nicotine in plasma after the start of delivery of the nicotine.
Rows 9-16:
Show the day 4 pre- and post-dose concentrations of nicotine in plasma.
Rows 17-18:
Show the day 1 pre-dose plasma concentrations of cotinine and N'-Nitrosonornicotine in plasma.
pc.xpt
pc.xpt
Row
STUDYID
DOMAIN
USUBJID
PCSEQ
PCGRPID
PCREFID
PCTESTCD
PCTEST
PCCAT
PCSPEC
PCORRES
PCORRESU
PCSTRESC
PCSTRESN
PCSTRESU
PCLLOQ
VISITNUM
VISIT
VISITDY
PCDTC
PCDY
PCTPT
PCTPTNUM
PCTPTREF
PCRFTDTC
PCELTM
1
A123
PC
A2008
1
Day 1
A10
NICOTNE
Nicotine
ANALYTE
PLASMA
<0.1
ng/mL
<0.1
ng/mL
0.10
1
DAY 1
1
2001-02-01T07:15
1
45 MIN PREDOSE
1
Day 1 Dose
2021-02-01T08:00
-PT45M
2
A123
PC
A2008
2
Day 1
A11
NICOTINE
Nicotine
ANALYTE
PLASMA
<1.0
ng/mL
<1.0
0.10
1
Day1
1
2001-02-01T07:30
1
30 MIN PREDOSE
2
Day 1 Dose
2021-02-01T08:00
-PT30M
3
A123
PC
A2008
3
Day 1
A12
NICOTINE
Nicotine
ANALYTE
PLASMA
<1.0
ng/mL
<0.1
ng/mL
0.10
1
DAY 1
1
2001-02-01T07:45
1
15 MIN PREDOSE
3
Day 1 Dose
2021-02-01T08:00
-PT15M
4
A123
PC
A2008
4
Day 1
A13
NICOTINE
Nicotine
ANALYTE
PLASMA
1.5
ng/mL
1.5
1.5
ng/mL
0.10
1
DAY 1
1
2001-02-01T08:02
1
2 MIN
4
Day 1 Dose
2021-02-01T08:00
PT2M
5
A123
PC
A2008
5
Day 1
A14
NICOTINE
Nicotine
ANALYTE
PLASMA
3.0
ng/mL
3.0
3.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T08:04
1
4 MIN
5
Day 1 Dose
2021-02-01T08:00
PT4M
6
A123
PC
A2008
6
Day 1
A15
NICOTINE
Nicotine
ANALYTE
PLASMA
8.0
ng/mL
8.0
8.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T08:08
1
8 MIN
6
Day 1 Dose
2021-02-01T08:00
PT8M
7
A123
PC
A2008
7
Day 1
A16
NICOTINE
Nicotine
ANALYTE
PLASMA
5.0.
ng/mL
5.0
5.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T09:00
1
60 MIN
7
Day 1 Dose
2021-02-01T08:00
PT60
8
A123
PC
A2008
8
Day 1
A16
NICOTINE
Nicotine
ANALYTE
PLASMA
3.0
ng/mL
3.0
3.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T010:00
1
120 MIN
8
Day 1 Dose
2021-02-01T08:00
PT120
9
A123
PC
A2008
9
Day 4
A17
NICOTINE
Nicotine
ANALYTE
PLASMA
5.44
ng/mL
5.44
5.44
ng/mL
0.10
2
DAY 4
4
2001-02-04T107:15
4
45 MIN PREDOSE
1
Day 4 Dose
2021-02-04T08:00
-PT45M
10
A123
PC
A2008
10
Day 4
A18
NICOTINE
Nicotine
ANALYTE
PLASMA
1.09
ng/mL
1.09
1.09
ng/mL
0.10
2
DAY 4
4
2001-02-04T07:30
4
30 MIN PREDOSE
2
Day 4 Dose
2021-02-04T08:00
-PT30M
11
A123
PC
A2008
11
Day 4
A19
NICOTINE
Nicotine
ANALYTE
PLASMA
<0.1
ng/mL
<0.1
ng/mL
0.10
2
DAY 4
4
2001-02-04T07:15
4
15 MIN REDOSE
3
Day 4 Dose
2021-02-04T08:00
-PT15M
13
A123
PC
A2008
12
Day 4
A20
NICOTINE
Nicotine
ANALYTE
PLASMA
3.41
ng/mL
3.41
3.41
ng/mL
0.10
2
DAY 4
4
2001-02-04T08.02
4
2 MIN
4
Day 4 Dose
2021-02-04T08:00
PT2M
13
A123
PC
A2008
13
Day 4
A21
NICOTINE
Nicotine
ANALYTE
PLASMA
<0.1
ng/mL
<0.1
ng/mL
0.10
2
DAY 4
4
2001-02-04T08:04
4
4 MIN
5
Day 4 Dose
2021-02-04T08:00
PT4M
14
A123
PC
A2008
14
Day 4
A22
NICOTINE
Nicotine
ANALYTE
PLASMA
8.74
ng/mL
8.74
8.74
ng/mL
0.10
2
DAY 4
4
2001-02-04T008.:08
4
8 MIN
6
Day 4 Dose
2021-02-04T08:00
PT8M
15
A123
PC
A2008
15
Day 4
A23
NICOTINE
Nicotine
ANALYTE
PLASMA
4.2
ng/mL
4.2
4.2
ng/mL
0.10
2
DAY 4
4
2001-02-04T09:00
4
60 MIN
7
Day 4 Dose
2021-04-11T08:00
PT160M
16
A123
PC
A2008
16
Day 4
A24
NICOTINE
Nicotine
ANALYTE
PLASMA
245
ng/mL
245
245
ng/mL
0.10
2
DAY 4
4
2001-02-04T010:00
4
120 MIN
8
Day 4 Dose
2021-04-11T08:00
PT120M
17
A123
PC
A2008
17
Day 1
A10
COTININE
Cotinine
ANALYTE
PLASMA
1
ng/mL
1
1
ng/mL
.075
1
DAY 1
1
2001-02-01T07:15
1
45 MIN PREDOSE
1
Day 1 Dose
2021-02-01T08:00
-PT45M
18
A123
PC
A2008
18
Day 1
A10
NNN
N'-Nitrosonornicotine
ANALYTE
PLASMA
<0.1
pg/mL
<.3
pg/mL
0.3
1
DAY 1
1
2001-02-01T07:15
1
45 MIN PREDOSE
1
Day 1 Dose
2021-02-01T08:00
-PT45M
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Example
In this PK study, Cmax, time to reachCmax(tmax), and the baseline-corrected area under the plasma concentration–time curves (i) from start of product use (t0) to the last quantifiable nicotine concentration time point (AUC0-last) and (ii) fromt0to 10 minutes aftert0(AUC0-10’). The pharmacokinetic parameters were derived from plasma nicotine concentrations-versus-time data by means of noncompartmental analysis and corrected for baseline where the baseline (C0) was defined as the average concentration of the 3 time points prior tot0(45, 30, and 15 minutes prior tot0). The analysis methods for the baseline corrected values were provided in the study protocol.
This example shows the PP parameters calculated from time-concentration profiles for the nicotine for one subject at day 1. Typically, the same PP 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; or (8) LAMZLL, Lambda z Lower Limit. These PP parameters are included in the controlled terminology.
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.
Rows 5-6:
Show parameter TMAX for cotinine and NNN.
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
A123
PP
A2008
1
DAY1
TMAX
Time of CMAX
NICOTINE
5
m
5
5
m
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2022-01-07
2021-02-08T08:00
2
A123
PP
A2008
2
DAY1
CMAX
Max Conc
NICOTINE
13
ng/mL
13
13
ng/mL
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2022-01-07
2021-02-08T08:00
3
A123
PP
A2008
3
DAY1
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
2022-01-07
2021-02-08T08:00
4
A123
PP
A2008
4
DAY1
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
2022-01-07
2021-02-08T08:00
0
10
5
A123
PP
A2008
5
DAY1
TMAX
Time of CMAX
COTININE
6
m
6
6
m
PLASMA
non-compartmental analysis. and corrected for baseline
1
DAY 1
2022-01-07
2021-02-08T08:00
6
A123
PP
A2008
6
DAY1
TMAX
Time of CMAX
NNN
7
m
7
7
m
PLASMA
non-compartmental analysis. and corrected for baseline