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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 assay used was 0/1 ng/ml , the PCULOQ was 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 in plasma after the start of delivery of the nicotine.
Rows 8-17Show day 1 pre- and post-dose concentrations of nicotine 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 1A15NICOTINENICOTINEANALYTEPLASMA8.0ng/mL8.08.0ng/mL
0.10
1DAY 112001-02-01T08:0818M6Day 1 Dose2001-02-01T08:00PT8M
7ABC-123PC123-00017Day 1A16NICOTINENICOTINEANALYTEPLASMA5.0.ng/mL5.05.0ng/mL
0.10
1DAY 112001-02-01T09:00160M7Day 1 Dose2001-02-01T08:00PT60
8ABC-123PC123-00018Day 1A16NICOTINENICOTINEANALYTEPLASMA3.0ng/mL3.03.0ng/mL
0.10201DAY 112001-02-01T010:001120M8Day 1 Dose2001-02-01T08:00PT120
9ABC-123PC123-00019Day 4A17NICOTINENICOTINEANALYTEPLASMA5.44ng/mL5.445.44ng/mL
0.10202DAY 442001-02-04T107:15445MIN  PREDOSE1Day 4 Dose2001-02-04T08:00-PT45M
10ABC-123PC123-000110Day 4A18NICOTINENICOTINEANALYTEPLASMA1.09ng/mL1.091.09ng/mL
0.10202DAY 442001-02-04T07:30430MIN PREDOSE2Day 4 Dose2001-02-04T08:00-PT30M
12ABC-123PC123-000111Day 4A19NICOTINENICOTINEANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10202DAY 442001-02-04T07:15415 MIN REDOSE3Day 4 Dose2001-02-04T08:00-PT15M
13ABC-123PC123-000112Day 4A20NICOTINENICOTINEANALYTEPLASMA3.41ng/mL3.413.41ng/mL
0.10202DAY 442001-02-04T08.0242M4Day 4 Dose2001-02-04T08:00PT2M
14ABC-123PC123-000113Day 4A21NICOTINENICOTINEANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10202DAY 442001-02-04T08:0444M5Day 4 Dose2001-02-04T08:00PT4M
15ABC-123PC123-000114Day 4A22NICOTINENICOTINEANALYTEPLASMA8.74ng/mL8.748.74ng/mL
0.10202DAY 442001-02-04T008.:0848M6Day 4 Dose2001-02-04T08:00PT8M
16ABC-123PC123-000115Day 4A23NICOTINENICOTINEANALYTEPLASMA4.2ng/mL4.24.2ng/mL
0.10202DAY 442001-02-04T09:00460M7Day 4 Dose2001-04-11T08:00PT160M
17ABC-123PC123-000116Day 4A24NICOTINENICOTINEANALYTEPLASMA245ng/mL245245ng/mL
0.105002DAY 442001-02-04T010:004120M8Day 4 Dose2001-04-11T08:00PT120M
18ABC-123PC123-000117Day 1A10COTININECOTININEANALYTEPLASMA<0.1ng/mL





1DAY 112001-02-01T07:15145MIN  PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M
19ABC-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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