Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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 non-compartmental noncompartmental analysis . and corrected for baseline where the baseline (C0) was defined as the average concentration of the three 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 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  Adjusted; (3. ) AUCIFO, AUC Infinity Obs, ; (4. ) AUCPEO, AUC %Extrapolation Obs  5- Obs;  (5) AUCTAU, AUC Over Dosing Interval  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.   

Dataset wrap
Namepp

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-286
 
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-289

Rowcaps
Rows 1-2:Show parameters TMAX and CMAX for day 1.
Rows 133-244:Show parameters AUC for Day 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. 
Dataset2
RowSTUDYIDDOMAINUSUBJIDPPSEQPPGRPIDPPTESTCDPPTESTPPCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSPECPPANMETHVISITNUMVISITPPDTCPPRFTDTCPPSTINTPPENINT
1A123PP2008A20081DAY1TMAXTime of CMAXNICOTINE5m55mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

2A123PP2008A20082DAY1CMAXMax ConcNICOTINE13ng/mL1313ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

3A123PP2008A20083DAY1AUCALLAUC AllNICOTINE11.4h*ng/mL11.411.4h*ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

34A123PP2008A20084DAY1AUCINTAUC from T1 to T2NICOTINE6.0h*ng/mL6.06.0h*ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00010
45A123PP2008A20085DAY1TMAXTime of CMAXCOTININE6m66mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00

56A123PP2008A20086DAY1TMAXTime of CMAXNNN7m77mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12022-01-072021-02-08T08:00