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1: Discuss the PCTEST and PCTESTCD Controlled Terminology. They are always measuring nicotine. |
This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine nicotine. Two different nicotine products were used in the study. Each product was evaluated in a 180-minute test session ..1–3 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 More time points were are often used, ; these timepoints presented were used only for illustration to save space.).
(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 analysis. and corrected for baseline where the baseline (C0) was defined as the average concentration of the three 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.
The PCLLOQ for the assay used was 0/1 ng/ml , the PCULOQ was not reportedThe PCLLOQ for the analytes measured were reported; PCULOQs were not reported.
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| Rows 1-3: | Show the day 1 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 post drug 1 concentrations of nicotine in plasma after the start of delivery of the nicotine. | | Rows 89-17 16: | Show the day 1 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. |
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| Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCGRPID | PCREFID | PCTESTCD | PCTEST | PCCAT | PCSPEC | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESUPCSTAT | PCLLOQ | PCULOQ | VISITNUM | VISIT | VISITDY | PCDTC | PCDY | PCTPT | PCTPTNUM | PCTPTREF | PCRFTDTC | PCELTM |
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| 1 | ABC-123A123 | PC | 123-0001A2008 | 1 | Day 1 | A10 | NICOTNE | NICOTINE Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45MIN 45 MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M | | 2 | ABC-123A123 | PC | 123-0001A2008 | 2 | Day 1 | A11 | NICOTINE | | ANALYTE | PLASMA | <1.0 | ng/mL | <1.0 |
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| 0.10 | 1 | Day1 | 1 | 2001-02-01T07:30 | 1 | 30 MIN PREDOSE | 2 | Day 1 Dose | 20012021-02-01T08:00 | -PT30M | | 3 | ABC-123A123 | PC | 123-0001A2008 | 3 | Day 1 | A12 | NICOTINE | NICOTINE Nicotine | ANALYTE | PLASMA | <1.0 | ng/mL | <0.1 |
| ng/mL | 0.10 | 20 | 1 | DAY 1 | 1 | 2001-02-01T07:45 | 1 | 15 MIM MIN PREDOSE | 3 | Day 1 Dose | 20012021-02-01T08:00 | -PT15M | | 4 | ABC-123A123 | PC | 123-0001A2008 | 4Day1 | Day 1 | A13 | NICOTINE | NICOTINE Nicotine | ANALYTE | PLASMA | 1.5 | ng/mL | 1.5 | 1.5 | ng/mL | 0.10 | 500 | 1 | DAY 1 | 1 | 2001-02-01T08:02 | 12M | 2 MIN | 4 | Day 1 Dose | 20012021-02-01T08:00 | PT2M | | 5 | ABC-123A123 | PC | 123-0001A2008 | 5 | Day 1 | A14 | NICOTINE | NICOTINE Nicotine | ANALYTE | PLASMA | 3.0 | ng/mL | 3.0 | 3.0 | ng/mL | 0.10 | 500 | 1 | DAY 1 | 1 | 2001-02-01T08:04 | 14M | 4 MIN | 5 | Day 1 Dose | 20012021-02-01T08:00 | PT4M | | 6 | ABC-123A123 | PC | 123-0001A2008 | 6 | Day 1 | A15 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 8.0 | ng/mL | 8.0 | 8.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T08:08 | 18M | 8 MIN | 6 | Day 1 Dose | 20012021-02-01T08:00 | PT8M | | 7 | ABC-123A123 | PC | 123-0001A2008 | 7 | Day 1 | A16 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 5.0. | ng/mL | 5.0 | 5.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T09:00 | 160M | 60 MIN | 7 | Day 1 Dose | 20012021-02-01T08:00 | PT60 | | 8 | ABC-123A123 | PC | 123-0001A2008 | 8 | Day 1 | A16 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 3.0 | ng/mL | 3.0 | 3.0 | ng/mL | 0.1020 | 1 | DAY 1 | 1 | 2001-02-01T010:00 | 1120M | 120 MIN | 8 | Day 1 Dose | 20012021-02-01T08:00 | PT120 | | 9 | ABC-123A123 | PC | 123-0001A2008 | 9 | Day 4 | A17 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 5.44 | ng/mL | 5.44 | 5.44 | ng/mL | 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T107:15 | 4 | 45MIN 45 MIN PREDOSE | 1 | Day 4 Dose | 20012021-02-04T08:00 | -PT45M | | 10 | ABC-123A123 | PC | 123-0001A2008 | 10 | Day 4 | A18 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 1.09 | ng/mL | 1.09 | 1.09 | ng/mL | 0.1020 | 2 | DAY 4 | 4 | 2001-02-04T07:30 | 4 | 30MIN 30 MIN PREDOSE | 2 | Day 4 Dose | 20012021-02-04T08:00 | -PT30M | | 1211 | ABC-123A123 | PC | 123-0001A2008 | 11 | Day 4 | A19 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T07:15 | 4 | 15 MIN REDOSE | 3 | Day 4 Dose | 20012021-02-04T08:00 | -PT15M | | 13 | ABC-123A123 | PC | 123-0001A2008 | 12 | Day 4 | A20 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 3.41 | ng/mL | 3.41 | 3.41 | ng/mL | 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T08.02 | 42M | 2 MIN | 4 | Day 4 Dose | 20012021-02-04T08:00 | PT2M | | 1413 | ABC-123A123 | PC | 123-0001A2008 | 13 | Day 4 | A21 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T08:04 | 44M | 4 MIN | 5 | Day 4 Dose | 20012021-02-04T08:00 | PT4M | | 1514 | ABC-123A123 | PC | 123-0001A2008 | 14 | Day 4 | A22 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 8.74 | ng/mL | 8.74 | 8.74 | ng/mL | 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T008.:08 | 48M | 8 MIN | 6 | Day 4 Dose | 20012021-02-04T08:00 | PT8M | | 1615 | ABC-123A123 | PC | 123-0001A2008 | 15 | Day 4 | A23 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 4.2 | ng/mL | 4.2 | 4.2 | ng/mL | 0.1020 | 2 | DAY 4 | 4 | 2001-02-04T09:00 | 460M | 60 MIN | 7 | Day 4 Dose | 20012021-04-11T08:00 | PT160M | | 1716 | ABC-123A123 | PC | 123-0001A2008 | 16 | Day 4 | A24 | NICOTINENICOTINE | Nicotine | ANALYTE | PLASMA | 245 | ng/mL | 245 | 245 | ng/mL | 0.10 | 500 | 2 | DAY 4 | 4 | 2001-02-04T010:00 | 4120M | 120 MIN | 8 | Day 4 Dose | 20012021-04-11T08:00 | PT120M | | 1817 | ABC-123A123 | PC | 123-0001A2008 | 17 | Day 1 | A10 | COTININECOTININE | Cotinine | ANALYTE | PLASMA | 1 | ng/mL | 1 | <0.1 | ng/mL | .075 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45MIN 45 MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M | | 1918 | ABC-123A123 | PC | 123-0001A2008 | 18 | Day 1 | A10 | NNN | N'-Nitrosonornicotine | ANALYTE | PLASMA | <0.1 | pg/mL | <.3 |
| pg/mL | 0.3 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45MIN 45 MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M |
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