You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 15 Next »

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 a 180 minute test session.  There was 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).  

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 8-16:Show the Day 4 pre- and post-dose concentrations of nicotine in plasma.
Rows 17-18:Show the Day 1 pre-dose plasma concentrations of cotinine and N'-Nitrosonornicotine in plasma.

pc.xpt

pc.xpt

RowSTUDYIDDOMAINUSUBJIDPCSEQPCGRPIDPCREFIDPCTESTCDPCTESTPCCATPCSPECPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCSTATPCLLOQVISITNUMVISITVISITDYPCDTCPCDYPCTPTPCTPTNUMPCTPTREFPCRFTDTCPCELTM
1ABC-123PC123-00011Day 1A10NICOTNENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.101DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M
2ABC-123PC123-00012Day 1A11NICOTINE

Nicotine

ANALYTEPLASMA<1.0ng/mL<1.0


0.101Day112001-02-01T07:30130 MIN PREDOSE2Day 1 Dose2001-02-01T08:00-PT30M
3ABC-123PC123-00013Day 1A12NICOTINENicotineANALYTEPLASMA<1.0ng/mL<0.1
ng/mL
0.101DAY 112001-02-01T07:45115 MIN PREDOSE3Day 1 Dose2001-02-01T08:00-PT15M
4ABC-123PC123-00014Day1 A13NICOTINENicotineANALYTEPLASMA1.5ng/mL1.51.5ng/mL
0.101DAY 112001-02-01T08:0212 MIN4Day 1 Dose2001-02-01T08:00PT2M
5ABC-123PC123-00015Day 1A14NICOTINENicotineANALYTEPLASMA3.0ng/mL3.03.0ng/mL
0.101DAY 112001-02-01T08:0414 MIN5Day 1 Dose2001-02-01T08:00PT4M
6ABC-123PC123-00016Day 1A15NICOTINENicotineANALYTEPLASMA8.0ng/mL8.08.0ng/mL
0.101DAY 112001-02-01T08:0818 MIN6Day 1 Dose2001-02-01T08:00PT8M
7ABC-123PC123-00017Day 1A16NICOTINENicotineANALYTEPLASMA5.0.ng/mL5.05.0ng/mL
0.101DAY 112001-02-01T09:00160 MIN7Day 1 Dose2001-02-01T08:00PT60
8ABC-123PC123-00018Day 1A16NICOTINENicotineANALYTEPLASMA3.0ng/mL3.03.0ng/mL
0.101DAY 112001-02-01T010:001120 MIN8Day 1 Dose2001-02-01T08:00PT120
9ABC-123PC123-00019Day 4A17NICOTINENicotineANALYTEPLASMA5.44ng/mL5.445.44ng/mL
0.102DAY 442001-02-04T107:15445 MIN PREDOSE1Day 4 Dose2001-02-04T08:00-PT45M
10ABC-123PC123-000110Day 4A18NICOTINENicotineANALYTEPLASMA1.09ng/mL1.091.09ng/mL
0.102DAY 442001-02-04T07:30430 MIN PREDOSE2Day 4 Dose2001-02-04T08:00-PT30M
11ABC-123PC123-000111Day 4A19NICOTINENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.102DAY 442001-02-04T07:15415 MIN REDOSE3Day 4 Dose2001-02-04T08:00-PT15M
13ABC-123PC123-000112Day 4A20NICOTINENicotineANALYTEPLASMA3.41ng/mL3.413.41ng/mL
0.102DAY 442001-02-04T08.0242 MIN4Day 4 Dose2001-02-04T08:00PT2M
13ABC-123PC123-000113Day 4A21NICOTINENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.102DAY 442001-02-04T08:0444 MIN5Day 4 Dose2001-02-04T08:00PT4M
14ABC-123PC123-000114Day 4A22NICOTINENicotineANALYTEPLASMA8.74ng/mL8.748.74ng/mL
0.102DAY 442001-02-04T008.:0848 MIN6Day 4 Dose2001-02-04T08:00PT8M
15ABC-123PC123-000115Day 4A23NICOTINENicotineANALYTEPLASMA4.2ng/mL4.24.2ng/mL
0.102DAY 442001-02-04T09:00460 MIN7Day 4 Dose2001-04-11T08:00PT160M
16ABC-123PC123-000116Day 4A24NICOTINENicotineANALYTEPLASMA245ng/mL245245ng/mL
0.102DAY 442001-02-04T010:004120 MIN8Day 4 Dose2001-04-11T08:00PT120M
17ABC-123PC123-000117Day 1A10COTININECotinine ANALYTEPLASMA1ng/mL11ng/mL
.0751DAY 112001-02-01T07:15145 MIN  PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M
18ABC-123PC123-000118Day 1A10NNNN'-NitrosonornicotineANALYTEPLASMA<0.1pg/mL<.3
pg/mL
0.31DAY 112001-02-01T07:15145 MIN  PREDOSE1Day 1 Dose2001-02-01T08:00-PT45M

Dataset Debug Message

There are four leading, trailing, or non-breaking spaces in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

  • No labels