This example shows PK parameters calculated from time-concentration profiles for the parent drug and 1 metabolite in plasma and urine nicotine for one subject at Day 1. Note that PPRFTDTC is populated in order to link the PP records to the respective PC records. In this example, PPSPEC is null for observed total clearance (PPTESTCD = "CLO") records because it is calculated from multiple specimen sources (i.e., plasma and urine).
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Rows 1-12:2 | Show parameters TMAX and CMAX for day 1. | Rows 13-24: | Show parameters for day 4AUC 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. | |
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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_PAR | TMAX | Time of CMAX | NICOTINE PARENT | 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_PAR | CMAX | Max Conc | NICOTINE PARENT | 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_PAR | AUCALL | AUC All | NICOTINE PARENT | 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 | 34 | DAY1_PAR | AUCINT | AUC from T1 to T2 | NICOTINE PARENT | 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 | |
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