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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 (Section 3.3.3.2, Pharmacokinetics Concentration and Parameters (PC, PP)). Otherwise, these biomarkers would be represented in the Laboratory Testing Results (LB) domain.
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