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Pharmacokinetics Concentrations (PC) is a findings domain used for the concentrations of drugs analyte or metabolites in biological fluids (e.g. blood, urine, saliva, breast milk ) or tissues as a function of time. The measuring of nicotine blood concentrations after a subject is exposed to a tobacco product is often performed. Information about sampling for pharmacokinetic (PK) concentration is collected on CRFs with the goal to reconcile or link sampling information (e.g., collection timing and specimen volumes) with PK concentration results provided by the laboratory. Tabulation PC records are compiled when joining CRF sampling information and PK concentration results. This is similar to scenario 1 in Section 2.7.6.9,  CDASH Laboratory Test Results (LB).

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1. The date and time of PK sample collections for the scenarios listed below. Note that the sampling approach may depend on how the body metabolizes and clears the analyte.
   1. Fixed defined time points (e.g., 4 HRS POSTDOSE)
   2. Across a collection interval (e.g., 2-4 HRS POSTDOSE)
2. Specimen properties (e.g., pH, specimen volume)

Note that specimens collected to measure drug study product (e.g., usually nicotine) concentration

In the case of fixed time points, the date (PCDAT) and time (PCTIM) of collection for each sample is recorded on the CRF. The protocol defines the time points at which samples are to be collected in relation to an intervention such as exposure to product. This "reference" is depicted in Figure 1 by the longer vertical line and would correspond to a date and time in the Exposure as Collected (EC) or Exposure (EX) domain.

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