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In this PK study, C_max, time to reach C_max (t_max), 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 (AUC_0-last) and (ii) from t₀ to 10 minutes after t₀ (AUC_0-10’). The pharmacokinetic parameters were derived from plasma nicotine concentrations-versus-time data by means of noncompartmental analysis and corrected for baseline where the baseline (C₀) was defined as the average concentration of the 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 PP This example shows PK parameters calculated from time-concentration profiles for the parent drug and 1 metabolite in plasma and urine for one subjectnicotine for one subject at day 1. Typically, the same 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. 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).

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; or (8) LAMZLL, Lambda z Lower Limit. These PP parameters are included in the controlled terminology.