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This example shows the 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 controlled terminology.
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| Rows 1-2: | Show parameters TMAX and CMAX for day 1. | | Rows 13-24: | Show parameters AUC for Day 1. Note 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. | |
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| Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPGRPID | PPTESTCD | PPTEST | PPCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSPEC | PPANMETH | VISITNUM | VISIT | PPDTC | PPRFTDTC | PPSTINT | PPENINT |
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| 1 | ABC-123 | PP | 123-0001 | 1 | DAY1 | 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 |
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| | 2 | ABC-123 | PP | 123-0001 | 2 | DAY1 | 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 |
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| | 3 | ABC-123 | PP | 123-0001 | 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 | 2002-01-07 | 2001-02-01T08:00 |
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| | 3 | ABC-123 | PP | 123-0001 | 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 | 2002-01-07 | 2001-02-01T08:00 | 0 | 10 | | 4 | ABC-123 | PP | 123-0001 | 5 | DAY1 | 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 |
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| | 5 | ABC-123 | PP | 123-0001 | 6 | DAY1 | TMAX | Time of CMAX | NNN | 7 | m | 7 | 7 | m | PLASMA | non-compartmental analysis. and corrected for baseline | 1 | DAY 1 | 2002-01-07 | 2001-02-01T08:00 |
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