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1: Discuss the PCTEST and PCTESTCD Controlled Terminology. They are always measuring nicotine. 

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.).  

(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 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 analytes measured were reported, the PCULOQs were not reported


Rows 1-3:Show the Day 1 pre-dose concentrations of nicotine in plasma at 45, 30 and 15 min before start of delivery of the nicotine. PCDTC is populated to indicate when these specimens were collected
Rows 4-8:Show the Day 1 post drug concentrations of nicotine in plasma after the start of delivery of the nicotine.
Rows 8-16Show the Day 4 pre- and post-dose concentrations of nicotine in plasma.
Rows 9-10Show the Day 1 pre-dose plasma concentrations of cotinine and N'-Nitrosonornicotine in plasma.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

pc.xpt

pc.xpt

RowSTUDYIDDOMAINUSUBJIDPCSEQPCGRPIDPCREFIDPCTESTCDPCTESTPCCATPCSPECPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCSTATPCLLOQPCULOQVISITNUMVISITVISITDYPCDTCPCDYPCTPTPCTPTNUMPCTPTREFPCRFTDTCPCELTM
1ABC-123PC123-00011Day 1A10NICOTNENicotine ANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10
1DAY 112001-02-01T07:15145MIN  PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M
2ABC-123PC123-00012Day 1A11NICOTINE

Nicotine  


ANALYTEPLASMA<1.0ng/mL<1.0


0.10
1Day112001-02-01T07:30130 MIN PREDOSE2Day 1 Dose2001-02-01T08:00-PT30M
3ABC-123PC123-00013Day 1A12NICOTINENicotine  ANALYTEPLASMA<1.0ng/mL<0.1
ng/mL
0.10201DAY 112001-02-01T07:45115 MIM PREDOSE3Day 1 Dose2001-02-01T08:00-PT15M
4ABC-123PC123-00014Day1 A13NICOTINENicotine  ANALYTEPLASMA1.5ng/mL1.51.5ng/mL
0.105001DAY 112001-02-01T08:0212M4Day 1 Dose2001-02-01T08:00PT2M
5ABC-123PC123-00015Day 1A14NICOTINENicotine  ANALYTEPLASMA3.0ng/mL3.03.0ng/mL
0.105001DAY 112001-02-01T08:0414M5Day 1 Dose2001-02-01T08:00PT4M
6ABC-123PC123-00016Day 1A15NICOTINENicotine  ANALYTEPLASMA8.0ng/mL8.08.0ng/mL
0.10
1DAY 112001-02-01T08:0818M6Day 1 Dose2001-02-01T08:00PT8M
7ABC-123PC123-00017Day 1A16NICOTINENicotine  ANALYTEPLASMA5.0.ng/mL5.05.0ng/mL
0.10
1DAY 112001-02-01T09:00160M7Day 1 Dose2001-02-01T08:00PT60
8ABC-123PC123-00018Day 1A16NICOTINENicotine  ANALYTEPLASMA3.0ng/mL3.03.0ng/mL
0.10201DAY 112001-02-01T010:001120M8Day 1 Dose2001-02-01T08:00PT120
9ABC-123PC123-00019Day 4A17NICOTINENicotine  ANALYTEPLASMA5.44ng/mL5.445.44ng/mL
0.10202DAY 442001-02-04T107:15445MIN  PREDOSE1Day 4 Dose2001-02-04T08:00-PT45M
10ABC-123PC123-000110Day 4A18NICOTINENicotine  ANALYTEPLASMA1.09ng/mL1.091.09ng/mL
0.10202DAY 442001-02-04T07:30430MIN PREDOSE2Day 4 Dose2001-02-04T08:00-PT30M
11ABC-123PC123-000111Day 4A19NICOTINENicotine  ANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10202DAY 442001-02-04T07:15415 MIN REDOSE3Day 4 Dose2001-02-04T08:00-PT15M
13ABC-123PC123-000112Day 4A20NICOTINENicotine  ANALYTEPLASMA3.41ng/mL3.413.41ng/mL
0.10202DAY 442001-02-04T08.0242M4Day 4 Dose2001-02-04T08:00PT2M
13ABC-123PC123-000113Day 4A21NICOTINENicotine  ANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10202DAY 442001-02-04T08:0444M5Day 4 Dose2001-02-04T08:00PT4M
14ABC-123PC123-000114Day 4A22NICOTINENicotine  ANALYTEPLASMA8.74ng/mL8.748.74ng/mL
0.10202DAY 442001-02-04T008.:0848M6Day 4 Dose2001-02-04T08:00PT8M
15ABC-123PC123-000115Day 4A23NICOTINENicotine  ANALYTEPLASMA4.2ng/mL4.24.2ng/mL
0.10202DAY 442001-02-04T09:00460M7Day 4 Dose2001-04-11T08:00PT160M
16ABC-123PC123-000116Day 4A24NICOTINENicotine  ANALYTEPLASMA245ng/mL245245ng/mL
0.105002DAY 442001-02-04T010:004120M8Day 4 Dose2001-04-11T08:00PT120M
17ABC-123PC123-000117Day 1A10COTININECotinine ANALYTEPLASMA<0.1ng/mL





1DAY 112001-02-01T07:15145MIN  PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M
18ABC-123PC123-000118Day 1A10NNNN'-NitrosonornicotineANALYTEPLASMA<0.1pg/mL<.3
pg/mL
0.3
1DAY 112001-02-01T07:15145MIN  PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M

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