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Description

Pharmacokinetics Concentrations (PC) is a findings 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 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).

The goals of the PC domain are:

• 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:

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 (e.g., 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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