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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

RowSTUDYIDDOMAINUSUBJIDPPSEQPPGRPIDPPTESTCDPPTESTPPCATPPORRESPPORRESUPPSTRESCPPSTRESNPPSTRESUPPSPECPPANMETHVISITNUMVISITPPDTCPPRFTDTCPPSTINTPPENINT
1ABC-123PP123-00011DAY1_PARTMAXTime of CMAXNICOTINE5m55mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12002-01-072001-02-01T08:00

2ABC-123PP123-00012DAY1_PARCMAXMax ConcNICOTINE13ng/mL1313ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12002-01-072001-02-01T08:00

3ABC-123PP123-00013DAY1_PARAUCALLAUC AllNICOTINE11.4h*ng/mL11.411.4h*ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12002-01-072001-02-01T08:00

3ABC-123PP123-00014DAY1_PARAUCINTAUC from T1 to T2NICOTINE6.0h*ng/mL6.06.0h*ng/mLPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12002-01-072001-02-01T08:00010
4ABC-123PP123-00015
TMAXTime of CMAXCOTININE6m66mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12002-01-072001-02-01T08:00

5ABC-123PP123-00016
TMAXTime of CMAXNNN7m77mPLASMAnon-compartmental analysis. and corrected for baseline1DAY 12002-01-072001-02-01T08:00

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