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  1. The Pharmacokinetics Concentrations (PC) domain represents concentration measurements for administered compounds and their metabolites in a sample. The sample may be from an individual or a pool. In addition to concentration measurements, specimen properties (e.g., volume, pH) are handled as separate tests in this dataset.

  2. The intent of the PC domain is to accurately and clearly represent the raw bioanalytical data (e.g., unaltered and non-transformed drug concentration data). Transformations for toxicokinetics (e.g., BQL values treated as zero) can be described in SUPPPC and PCCALCN.

  3. This domain should support creation of time-series graphs and automatic calculation of pharmacokinetic parameters from sets of related plasma concentrations.
  4. The timing variables needed for toxicokinetic analysis are:
    1. PCNOMDY
    2. PCTPTREF
    3. PCELTM
  5. The combination of NOMDY and --TPTREF, when properly constructed, allows grouping within each time series of the PC records with their respective Pharmacokinetics Parameters (PP) records. In order to achieve this, ensure that the combination of PPNOMDY and PPTPTREF is equivalent to the combination of PCNOMDY and PCTPTREF.
    1. Similar to other domains, NOMDY in the PC domain should be used as a grouping variable. For example, if animal subjects are dosed on day 90 and have a scheduled 48-hour time point collection, PCDY is “92”; NOMDY is “90”, as the reported TK profile is of day 90.
    2. Because --TPTREF must identify a unique dose, it is recommended that ‑‑TPTREF include both the NOMDY and the time point description in order (e.g., “Day 1, Dose 1” and “Day 1, Dose 2” for twice-daily dosing); ambiguous references such as “Most recent dose” should be avoided.
  6. PCELTM must be populated with the nominal time from the reference (dose) in order to accurately construct a graph. Because PCELTM should be the timing used to calculate the profile, PCELTM should not be null for plasma concentrations used to calculate a profile. See Section 4.4.7.2.2, Planned Time Points Relative To a Fixed Reference Point, for further explanation about populating ISO 8601-conformant durations.
    1. When a pre-dose sample is collected as part of the profile analysis, then PCELTM must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under the curve.
    2. In studies with both pre-dose and immediate post-dose sampling, there should not be 2 “PT0H” records for the same profile. The pre-dose sampling should be represented by “PT0H” and the immediate post-dose sampling should be represented by a number slightly higher than zero but lower than the next time point post-dose. PCTPT would then be used to describe these as pre-dose and immediate post-dose, respectively.
  7. If the PCORRES result is outside the limit of quantification,
    1. PCSTRESN should be null and not populated with the value of zero.
    2. When appropriate, populate PCCALCN in the SUPPPC domain with the value used (See Section 4.5.1.1, Original and Standardized Results).
    3. When a measurement is identified as being below a limit of quantification threshold in PCSTRESC, both PCLLOQ and PCSTRESU must be populated; PCLLOQ states the level and PCSTRESU provides the units for PCLLOQ.
  8. Concentration records can be added for unscheduled tests. In this case, the planned fields and those that depend upon the planned fields are left null: PCTPT, PCTPTNUM, PCELTM, PCTPTREF, PCRFTDTC, and PCEVLINT.