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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 pouches. Three Two different nicotine pouches products were used in the study. Each pouch product was evaluated in a 180-minute test session . AUC and CMAX were to be determined.    The study consisted of a screening period, one day of admission, four separate days of on-site product use with 1–3 with 1-3 days in between each product use, and a 7-day safety follow-up period. Plasma samples were taken at 45, 30, and 15 minutes prior to the start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, and 120 , and 240 minutes after the start of product use. (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 using Phoenix WinNonlin (version 6.2, Pharsight Corp, Sunnyvale, California) and corrected for baseline following the method described by Kraiczi et al.30 whereby 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) of each visit from whose slope the elimination rate constant (k) was estimated and then used for the calculation of the baseline corrected values. 

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More time points are often used; these timepoints presented were used only for illustration to save space.)  

The PCLLOQ for the analytes measured were reported; PCULOQs were not reported.  

Dataset wrap
Namepc
Rowcaps
Rows 1-23:Show the day 1 pre-dose drug and metabolite concentrations of nicotine in plasma and urine.
Rows 3-4:Show day 1 pre-dose drug and metabolite concentrations in urine. Urine specimens may be collected over an interval; both PCDTC and PCENDTC have been populated with the same value to indicate that these specimens were collected at a point in time rather than over an interval.
Rows 5-6:Show specimen properties (VOLUME and PH) for the day 1 pre-dose urine specimens. These have a PCCAT value of "SPECIMEN PROPERTY".
Rows 7-12:Show day 1 post-dose drug and metabolite concentrations in plasma.
Rows 13-16:Show day 11 drug and metabolite concentrations in plasma.
Rows 17-20:Show day 11 drug and metabolite concentrations in urine specimens collected over an interval. The elapsed times for urine samples are calculated as the elapsed time (from the reference time point, PCTPTREF) to the end of the specimen collection interval. Elapsed time values that are the same for urine and plasma samples have been assigned the same value for PCTPT. For the urine samples, the value in PCEVLINT describes the planned evaluation (or collection) interval relative to the time point. The actual evaluation interval can be determined by subtracting PCDTC from PCENDTC.
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 concentrations of nicotine in plasma after the start of delivery of the nicotine. 
Rows 9-16:  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 plasmaRows 21-30:Show additional drug and metabolite concentrations and specimen properties related to the day 11 dose.
Dataset2
NICO_PAR
RowSTUDYIDDOMAINUSUBJIDPCSEQPCGRPIDPCREFIDPCTESTCDPCTESTPCCATPCSPECPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCSTATPCLLOQPCULOQVISITNUMVISITVISITDYPCDTCPCENDTCPCDYPCTPTPCTPTNUMPCTPTREFPCRFTDTCPCELTMPCEVLINT
1ABC-123A123PC123-0001A20081Day 1A554134-10NICO_PARA10NICOTNENicotineNICOTINE PARENTANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.10201DAY 112001-02-01T07:4515145MIN  45 MIN PREDOSE01Day 1 Dose20012021-02-01T08:00-PT45M

NICOTINE PARENT

PLASMA<1.0
30 MIN PREDOSE-PT30M2ABC-123A123PC123-0001A20082Day 21A554134-10DRGA_PARA11NICOTINE

Nicotine

Drug A Parent

ANALYTEPLASMA<1.0ng/mL<0<1.10ng/mL

0.10201DAY 1Day112001-02-01T07:4530115 MIM 30 MIN PREDOSE02Day 1 Dose20012021-02-01T08:00-PT15MPT30M
3ABC-123A123PC123-0001A20083Day  3 A554134-11DRGA_METDay 1A12NICOTINENicotineDrug A MetaboliteANALYTEPLASMA1<1.50ng/mL<2<0.1
ng/mL20.00105001DAY 112001-02-01T07:452001-02-01T07:4512M15 MIN PREDOSE03Day 1 Dose20012021-02-01T08:00PT2M-PT15M
4ABC-123A123PC123-0001A20084Day 1A554134-11DRGA_PARA13NICOTINENicotineDrug A ParentANALYTEPLASMA31.05ng/mL1.51.5<2ng/mL20.00105001DAY 112001-02-01T0701T08:452001-02-01T07:4514M2 MIN04Day 1 Dose20012021-02-01T08:00PT$MPT2M
5ABC-123A123PC123-0001A20085Day 1A554134-11A14VOLUMENICOTINEVolumeNicotineSPECIMEN PROPERTYANALYTEPLASMA83.0ng/mL100100mL3.03.0ng/mL0.101DAY 112001-02-01T07:452001-02-01T07:4501T08:0418M4 MIN05Day 1 Dose20012021-02-01T08:00PT8MPT4M
6ABC-123A123PC123-0001A20086Day 1A554134-11A15PHNICOTINEPHNicotineSPECIMEN PROPERTYANALYTEPLASMA58.0ng/mL8.05.58.0ng/mL0.105.51DAY 112001-02-01T0701T08:452001-02-01T07:4508160M8 MIN06Day 1 Dose20012021-02-01T08:00PT60PT8M
7ABC-123A123PC123-0001A20087Day 1A554134-12DRGA_META16NICOTINENicotineDrug A MetaboliteANALYTEPLASMA35.0.ng/mL5.405.40ng/mL0.10201DAY 112001-02-01T09:30001120M60 MIN71.5Day 1 Dose20012021-02-01T08:00PT120PT60
8ABC-123A123PC123-0001A20088Day 1A554134-12DRGA_PARA16NICOTINENicotineDrug A ParentANALYTEPLASMA23.0ng/mL43.74043.740ng/mL0.10201DAY 112001-02-01T0901T010:30001240M120 MIN81.5Day 1 Dose20012021-02-01T08:00PT240MPT120
9ABC-123A123PC123-0001A20089Day 14A554134-13DRGA_META17NICOTINENicotineDrug A MetaboliteANALYTEPLASMA5.44ng/mL5.445.44ng/mL0.102021DAY 14142001-02-01T1404T107:0015146H45 MIN PREDOSE61Day 1 4 Dose20012021-02-01T0804T08:00PT6H00M-PT45M
10ABC-123A123PC123-0001A200810Day 14A554134-13DRGA_PARA18NICOTINENicotineDrug A ParentANALYTEPLASMA1.09ng/mL1.091.09ng/mL0.102012DAY 14142001-02-01T1404T07:0030146H30 MIN PREDOSE62Day 1 4 Dose20012021-02-01T0804T08:00PT6H-PT30M
11ABC-123A123PC123-0001A200811Day 14A554134-14DRGA_META19NICOTINENicotineDrug A MetaboliteANALYTEPLASMANOT DONE202DAY 222001-02-02T08:00224H24Day 1 Dose2001-02-01T08:00PT24H12ABC-123PC123-000112Day 1A554134-14DRGA_PARDrug A ParentANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.10202DAY 24242001-02-02T0804T07:00152424H15 MIN REDOSE243Day 1 4 Dose20012021-02-01T0804T08:00PT24H-PT15M
13ABC-123A123PC123-0001A20081312Day 114A554134-15DRGA_META20NICOTINENicotineDrug A MetaboliteANALYTEPLASMA3.41ng/mL3.413.41ng/mL0.102023DAY 1141142001-02-11T07:4511PREDOSE0Day 11 Dose04T08.0242 MIN4Day 4 Dose20212001-02-11T0804T08:00-PT15MPT2M
1413ABC-123A123PC123-0001A20081413Day 114A554134-15DRGA_PARA21NICOTINENicotineDrug A ParentANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.102023DAY 1141142001-02-11T0704T08:4504114PREDOSE4 MIN05Day 11 4 Dose20012021-02-11T0804T08:00-PT15MPT4M
1514ABC-123A123PC123-0001A20081514Day 114A554134-16DRGA_META22NICOTINENicotineDrug A MetaboliteANALYTEPLASMA8.74ng/mL8.748.74ng/mL0.102023DAY 1141142001-02-11T0904T008.:30081141H30MIN8 MIN61.5Day 11 4 Dose20012021-02-11T0804T08:00PT1H30MPT8M
1615ABC-123A123PC123-0001A20081615Day 114A554134-16DRGA_PARA23NICOTINENicotineDrug A ParentANALYTEPLASMA4.2ng/mL4.24.2ng/mL0.102032DAY 1141142001-02-11T0904T09:30001141H30MIN60 MIN71.5Day 11 4 Dose20012021-0204-11T08:00PT1H30MPT160M
1716ABC-123A123PC123-0001A20081716Day 114A554134-17DRGA_META24NICOTINENicotineDrug A MetaboliteANALYTEURINEPLASMA245ng/mL245245ng/mL2.005003DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H18ABC-123PC123-000118Day 11A554134-17DRGA_PARDrug A ParentANALYTEURINE13.1ng/mL13.113.1ng/mL2.005003DAY 110.102DAY 44112001-02-11T0804T010:002001-02-11T14:03116H6Day 11 Dose4120 MIN8Day 4 Dose2021-042001-02-11T08:00PT6H-PT6H19ABC-123PC123-000119Day 11A554134-17VOLUMEVolumeSPECIMEN PROPERTYURINE574mL574574mL3DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H20ABC-123PC123-000120Day 11A554134-17PHPHSPECIMEN PROPERTYURINE5.55.5PT120M
17A123PCA200817Day 1A10COTININECotinineANALYTEPLASMA15.53DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H21ABC-123PC123-000121Day 11A554134-18DRGA_METDrug A MetaboliteANALYTEPLASMA9.02ng/mL9.029.02ng/mL0.10203DAY 11112001-02-11T14:00116H6Day 11 Dose2001-02-11T08:00PT6H22ABC-123PC123-000122Day 11A554134-18DRGA_PARDrug A ParentANALYTEPLASMA1.18ng/mL1.181.18ng/mL0.100752031DAY 1111112001-02-11T14:00116H6Day 11 Dose01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
18A123PCA200818Day 1A10NNNN'-NitrosonornicotineANALYTEPLASMA<0.1pg/mL<.3
pg/mL0.31DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M2001-02-11T08:00PT6H23ABC-123PC123-000123Day 11A554134-19DRGA_METDrug A MetaboliteANALYTEURINE293ng/mL293293ng/mL2.003DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H24ABC-123PC123-000124Day 11A554134-19DRGA_PARDrug A ParentANALYTEURINE7.1ng/mL7.17.1ng/mL2.003DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H25ABC-123PC123-000125Day 11A554134-19VOLUMEVolumeSPECIMEN PROPERTYURINE363mL363363mL3DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H26ABC-123PC123-000126Day 11A554134-19PHPHSPECIMEN PROPERTYURINE5.55.55.53DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H27ABC-123PC123-000127Day 11A554134-20DRGA_METDrug A MetaboliteANALYTEURINE280ng/mL280280ng/mL2.004DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H28ABC-123PC123-000128Day 11A554134-20DRGA_PARDrug A ParentANALYTEURINE2.4ng/mL2.42.4ng/mL2.004DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H29ABC-123PC123-000129Day 11A554134-20VOLUMEVolumeSPECIMEN PROPERTYURINE606mL606606mL4DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H30ABC-123PC123-000130Day 11A554134-20PHPHSPECIMEN PROPERTYURINE5.55.55.54DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H31ABC-123PC123-000131Day 11A554134-21DRGA_METDrug A MetaboliteANALYTEPLASMA3.73ng/mL3.733.73ng/mL0.10204DAY 12122001-02-12T08:001224H24Day 11 Dose2001-02-11T08:00PT24H32ABC-123PC123-000132Day 11A554134-21DRGA_PARDrug A ParentANALYTEPLASMA<0.1ng/mL<0.1ng/mL0.10204DAY 12122001-02-12T08:001224H24Day 11 Dose2001-02-11T08:00PT24H