This is an example of an ADaM dataset designed to describe the main variables needed to perform a PK Parameter summary. The dataset described below is called ADPP and is based on the SDTM PP dataset shown below.
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 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 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; or (8) LAMZLL, Lambda z Lower Limit. These PP parameters are included in the controlled terminology.
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The ADaM ADSL associated with this study is not shown. An example on the creation of an ADSL for another study is provided here ADaM Example.ADSL Analysis Data Subject Level New
Values from ADSL and PP are combined to capture observations that can be summarized. This is just an example and does not mean to indicate that ADPP must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study. One item to note is the use of PARQUAL which is not yet included in any ADaMIG but will appear in a future version of the ADaM.
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