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Pharmacokinetics Concentrations (PC) is a findings Findings domain used for the concentrations of 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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• To standardize specimen collection details in the CRF for PK samples collected at fixed time points or over timed intervals
• To provide examples as to the collection of data that is closely related to PK sampling (e.g., subject's most recent exposure to product, exposure record considered to be the reference for timed PK samples)
• To document the data flow from the CRF to the tabaulation tabulation PC dataset

The CDASHIG PC domain defines fields for:

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Note that specimens collected to measure study product (e.g., usually nicotine) concentration at an instant in time are generally associated with specimen types such as plasma, serum, or whole blood. Specimens collected over a timed interval are generally associated with specimen types such as urine or feces.

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