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Description/Overview

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Pharmacokinetics Concentrations (PC) is a 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

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, specimen volumes) with PK concentration results provided by the laboratory.

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Tabulation PC records are compiled when joining CRF sampling information and PK concentration results. This is similar to scenario 1 in Section

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2.

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7.6.9,  CDASH Laboratory Test Results (LB).

The goals of the

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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 CDASHIG examples as to the collection of data that is closely related to PK sampling (e.g., subject's most recent exposure to study treatmentproduct, exposure record considered to be the reference for timed PK samples)
• To document the data flow from the CDASHIG CRF to the SDTMIG 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. Sample Specimen properties (e.g., pH, sample specimen volume)

Note that

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specimens collected to measure

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study product (usually nicotine) concentration at an instant in time are generally associated with specimen types such as plasma, serum, or whole blood.

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Specimens collected over a timed interval are generally associated with specimen types such as urine or feces.

PK Sample Collection at Fixed Time Points

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

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exposure to product. This "reference" is depicted

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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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PK Sample Collection Over a Time Interval

Similarly, for PK specimens collected to measure

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excretion over a time interval, PCDAT and PCTIM capture the start date and time of the interval collection. End date (PCENDAT) and end time (PCENTIM) capture the end of the timed interval collection. As with fixed-time point collections, these timed intervals are performed in relation to an intervention such as

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exposure to product. This "reference" is depicted

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in Figure 2 by the longer vertical line and would correspond to a date and time in the EC or EX domain.

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CM.CDASHIG-SDTMIG PK Data Flow

The concept map in Figure 3 illustrates the data flow from PK sample collection at the site through the tabulation of PK concentration and PK parameter results.

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Specification

Assumptions

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