(SENDIG v3.1.1) PC PP Multi-domain Example 2

This example shows data for 1 animal subject, where only the minimal amount of timing information was readily available electronically. The subject was dosed daily and sampled for 2 profiles, starting day 1 and day 14. A full profile was obtained from the subject on both occasions and analyzed for parent compound and 2 metabolites.

PC PP Cross-domain Example 2: PC

At a minimum, the nominal timing variables required for the analysis are PCNOMDY, PCTPTREF, and PCELTM; these timing variables have been populated, but PCDTC is null. PCRFTDTC is populated with only the date of dose as the time was not recorded in a manner readily available electronically. Although not crucial for the analysis, PCTPT was recorded and therefore populated in this example.

In this example, the sponsor chose to populate PCTPTNUM with a simple sequential sorting order; therefore, no timing information can be assumed from the data represented in this variable.

In the case of duration dosing (e.g., continuous infusion), all records can only have 1 reference time point; this must be consistent (i.e., always work from the start of the dose, or always work from the end of dose). If the end of dosing is used as the reference time point, then start time point = -PT1H for 1 hour infusion and immediate postdose would be PT0H.

The example shows the best practice of using PCCAT to differentiate in the dataset between the parent and metabolite. It also shows the best practice of populating PCNAM.

This example shows how PPTPTREF relates back to the PCTPTREF in the PC domain. 

For the dose date/time, the date is known, but not the exact time; therefore, PPRFTDTC is populated with the data portion only.

This example shows a SUPPPC domain to specify the PCCALCN value used for the PC records where the result fell below the limit of quantitation.