PC Concentrations Example 1

This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine  Two different nicotine products were used in the study. Each product was evaluated in 180 minute test session..1–3 days in between each product use. Plasma samples were taken at 45, 30, and 15 minutes prior start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120,  after start of product use. (More  time points were used, these timepoints were used only for illustration to save space.).  

(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 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 reported