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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

RowSTUDYIDDOMAINUSUBJIDPCSEQPCGRPIDPCREFIDPCTESTCDPCTESTPCCATPCSPECPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCLLOQVISITNUMVISITVISITDYPCDTCPCDYPCTPTPCTPTNUMPCTPTREFPCRFTDTCPCELTM
1A123PCA20081Day 1A10NICOTNENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.101DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
2A123PCA20082Day 1A11NICOTINE

Nicotine

ANALYTEPLASMA<1.0ng/mL<1.0

0.101Day112001-02-01T07:30130 MIN PREDOSE2Day 1 Dose2021-02-01T08:00-PT30M
3A123PCA20083Day 1A12NICOTINENicotineANALYTEPLASMA<1.0ng/mL<0.1
ng/mL0.101DAY 112001-02-01T07:45115 MIN PREDOSE3Day 1 Dose2021-02-01T08:00-PT15M
4A123PCA20084Day 1A13NICOTINENicotineANALYTEPLASMA1.5ng/mL1.51.5ng/mL0.101DAY 112001-02-01T08:0212 MIN4Day 1 Dose2021-02-01T08:00PT2M
5A123PCA20085Day 1A14NICOTINENicotineANALYTEPLASMA3.0ng/mL3.03.0ng/mL0.101DAY 112001-02-01T08:0414 MIN5Day 1 Dose2021-02-01T08:00PT4M
6A123PCA20086Day 1A15NICOTINENicotineANALYTEPLASMA8.0ng/mL8.08.0ng/mL0.101DAY 112001-02-01T08:0818 MIN6Day 1 Dose2021-02-01T08:00PT8M
7A123PCA20087Day 1A16NICOTINENicotineANALYTEPLASMA5.0.ng/mL5.05.0ng/mL0.101DAY 112001-02-01T09:00160 MIN7Day 1 Dose2021-02-01T08:00PT60
8A123PCA20088Day 1A16NICOTINENicotineANALYTEPLASMA3.0ng/mL3.03.0ng/mL0.101DAY 112001-02-01T010:001120 MIN8Day 1 Dose2021-02-01T08:00PT120
9A123PCA20089Day 4A17NICOTINENicotineANALYTEPLASMA5.44ng/mL5.445.44ng/mL0.102DAY 442001-02-04T107:15445 MIN PREDOSE1Day 4 Dose2021-02-04T08:00-PT45M
10A123PCA200810Day 4A18NICOTINENicotineANALYTEPLASMA1.09ng/mL1.091.09ng/mL0.102DAY 442001-02-04T07:30430 MIN PREDOSE2Day 4 Dose2021-02-04T08:00-PT30M
11A123PCA200811Day 4A19NICOTINENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.102DAY 442001-02-04T07:15415 MIN REDOSE3Day 4 Dose2021-02-04T08:00-PT15M
13A123PCA200812Day 4A20NICOTINENicotineANALYTEPLASMA3.41ng/mL3.413.41ng/mL0.102DAY 442001-02-04T08.0242 MIN4Day 4 Dose2021-02-04T08:00PT2M
13A123PCA200813Day 4A21NICOTINENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.102DAY 442001-02-04T08:0444 MIN5Day 4 Dose2021-02-04T08:00PT4M
14A123PCA200814Day 4A22NICOTINENicotineANALYTEPLASMA8.74ng/mL8.748.74ng/mL0.102DAY 442001-02-04T008.:0848 MIN6Day 4 Dose2021-02-04T08:00PT8M
15A123PCA200815Day 4A23NICOTINENicotineANALYTEPLASMA4.2ng/mL4.24.2ng/mL0.102DAY 442001-02-04T09:00460 MIN7Day 4 Dose2021-04-11T08:00PT160M
16A123PCA200816Day 4A24NICOTINENicotineANALYTEPLASMA245ng/mL245245ng/mL0.102DAY 442001-02-04T010:004120 MIN8Day 4 Dose2021-04-11T08:00PT120M
17A123PCA200817Day 1A10COTININECotinineANALYTEPLASMA1ng/mL11ng/mL.0751DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
18A123PCA200818Day 1A10NNNN'-NitrosonornicotineANALYTEPLASMA<0.1pg/mL<.3
pg/mL0.31DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

In this PK study, Cmax, time to reach Cmax (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) from t0 to 10 minutes after t0 (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 to t0 (45, 30, and 15 minutes prior to t0). 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.   

TOBA-286 - Getting issue details... STATUS   TOBA-289 - Getting issue details... STATUS

Rows 1-2:Show parameters TMAX and CMAX for day 1.
Rows 3-4: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

RowSTUDYIDDOMAINUSUBJIDPPSEQPPGRPIDPPTESTCDPPTESTPPCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSPECPPANMETHVISITNUMVISITPPDTCPPRFTDTCPPSTINTPPENINT
1A123PPA20081DAY1TMAXTime of CMAXNICOTINE5m55mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

2A123PPA20082DAY1CMAXMax ConcNICOTINE13ng/mL1313ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

3A123PPA20083DAY1AUCALLAUC AllNICOTINE11.4h*ng/mL11.411.4h*ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

4A123PPA20084DAY1AUCINTAUC from T1 to T2NICOTINE6.0h*ng/mL6.06.0h*ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00010
5A123PPA20085DAY1TMAXTime of CMAXCOTININE6m66mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

6A123PPA20086DAY1TMAXTime of CMAXNNN7m77mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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