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 PK PP parameters calculated from time-concentration profiles for the nicotine for one subject at Day day 1. Typically, the same PK 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 controlled terminology.
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-286 |
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| Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-289 |
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Rows 1-2: | Show parameters TMAX and CMAX for day 1. | Rows 133-244: | Show parameters AUC for Day 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. | Rows 5-6: | Show parameter TMAX for cotinine and NNN. |
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Dataset2 |
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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-123123-0001_PAR | TMAX | Time of CMAX | NICOTINE | 5 | m | 5 | 5 | m | PLASMA | non-compartmental analysis. and corrected for baseline | 1 | DAY 1 | 2002200101T08ABC-123123-0001_PAR | CMAX | Max Conc | NICOTINE | 13 | ng/mL | 13 | 13 | ng/mL | PLASMA | non-compartmental analysis. and corrected for baseline | 1 | DAY 1 | 2002200101T08ABC-123123-0001_PAR | 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 | 2002200101T083ABC-123123-0001_PAR | 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 | 2002200101T084ABC-123123-0001A2008 | 5 | DAY1 | TMAX | Time of CMAX | COTININE | 6 | m | 6 | 6 | m | PLASMA | non-compartmental analysis. and corrected for baseline | 1 | DAY 1 | 2002200101T085ABC-123123-0001A2008 | 6 | DAY1 | TMAX | Time of CMAX | NNN | 7 | m | 7 | 7 | m | PLASMA | non-compartmental analysis. and corrected for baseline | 1 | DAY 1 | 2002200101T08 |
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