SDTM Example.Pharmacokinetics Parameters

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 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. 

This example shows the PP parameters calculated from time-concentration profiles for the nicotine 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.

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 8.LAMZLL Lambda z Lower Limit. These PP parameters are included in the controlled terminology.