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The use of tobacco products result in the uptake of nicotine and a wide range of other chemicals. Biomarkers of exposure to tobacco and nicotine delivery products are limited to the chemicals taken up during product use or during exposure to product emissions. Total nicotine equivalents (TNE) is a biomarker of nicotine consumption, defined as the molar sum of the urinary concentrations of nicotine and all of its known metabolites. Typically, this includes total NICnicotine, total COTcotinine, total 3HC3-hydroxycotinine, and nicotine N-oxide , (NNO). Cotinine is a metabolite of nicotine and is a widely used biomarker of nicotine exposure. Nicotine replacement therapy and tobacco use can be distinguished by the detection of a tobacco-specific alkaloid, such as anabasine. Cotinine has 6 notable metabolites including: 3′3-hydroxycotinine, cotinine glucuronide, 5′5-hydroxycotinine, cotinine N-oxide, cotinine methonium ion, and norcotinine.

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Biomarkers of exposure may be used to evaluated the pharmacokinetics of tobacco products. After the specific tobacco product is used, these biomarkers are measured serially to determine well-defined pharmacokinetic parameters ( e.g., AUC, TMX, T 1/2 ), the concentration level at the pre-specified timepoints would be represented in the PC/PK SDTM domains (Pharmacokinetics Concentration and Parameters). Otherwise, these biomarkers would be represented in the Laboratory Testing Resutls Results (LB) domain. 

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