- The PP domain represents the pharmacokinetic parameter values for each of the time-concentration profiles.
- If a parameter needs to be qualified by an additional parameter, records for both parameters should be included (e.g., AUCLST and TLST).
- The combination of --NOMDY and --TPTREF, when properly constructed, allows grouping within each time series of the PC records with their respective PP records.
- In studies with serial sampling (i.e., all time points collected from a single animal in order to construct the time-concentration profile), then PCRFTDTC should match PPRFTDTC. Small animal toxicology studies often involve sparse sampling of time points; that is, due to blood volume collection in small animals, sometimes only 2-3 blood collections per day may be possible. In such cases the time-concentration profile may be constructed from 2-3 time points per animal across several animals. In cases of sparse sampling and composite time-concentration curves, it is acceptable to leave PPRFTDTC null. In the event that all subjects in a pool have the same reference time point date, it would also be acceptable to populate PPRFTDTC with the date (no time) that corresponds to the description in TPTREF.
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