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.

Rows 1-2:	Show parameters TMAX and CMAX for day 1.
Rows 13-24:	Show parameters AUC for Day 1. 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.

pp.xpt

Row	STUDYID	DOMAIN	USUBJID	PPSEQ	PPGRPID	PPTESTCD	PPTEST	PPCAT	PPORRES	PPORRESU	PPSTRESC	PPSTRESN	PPSTRESU	PPSPEC	PPANMETH	VISITNUM	VISIT	PPDTC	PPRFTDTC	PPSTINT	PPENINT
1	APP-123	PP	123-0001	1	DAY1	TMAX	Time of CMAX	NICOTINE	5	m	5	5	m	PLASMA	non-compartmental analysis. and corrected for baseline	1	DAY 1	2002-01-07	2001-02-01T08:00
2	APP-123	PP	123-0001	2	DAY1	CMAX	Max Conc	NICOTINE	13	ng/mL	13	13	ng/mL	PLASMA	non-compartmental analysis. and corrected for baseline	1	DAY 1	2002-01-07	2001-02-01T08:00
3	APP-123	PP	123-0001	3	DAY1	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	2002-01-07	2001-02-01T08:00
3	APP-123	PP	123-0001	4	DAY1	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	2002-01-07	2001-02-01T08:00	0	10
4	APP-123	PP	123-0001	5	DAY1	TMAX	Time of CMAX	COTININE	6	m	6	6	m	PLASMA	non-compartmental analysis. and corrected for baseline	1	DAY 1	2002-01-07	2001-02-01T08:00
5	APP-123	PP	123-0001	6	DAY1	TMAX	Time of CMAX	NNN	7	m	7	7	m	PLASMA	non-compartmental analysis. and corrected for baseline	1	DAY 1	2002-01-07	2001-02-01T08:00

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SDTM Example.Pharmacokinetics Parameters