Bioequivalence and Bioavailability Forum

Hi ElMaestro & Smitha,

❝ ❝ 2. a. If the actual time-point is used even if the sampling deviation is within the window

❝ ❝       period, is it appropriate? Is there an impact on the PK data e.g AUC?

❝

❝ I think it is common to use the nominal point for both plotting and AUC-calculation when the sample is inside the window (note: not all CROs apply windows). Otherwise use actual time for both.

I suggest to always use the actual time points (individual plots and NCA) and scheduled ones only for summary (by treatment) plots. Only once I saw a report where medians of actual time points were used. IMHO, a little bit over the top.

A note on “time allowance windows”. In most CROs the actual time point has to be recorded in the CRF anyhow. Only if a deviation from the scheduled time is larger than allowed, an explanation has to be given in the CRF (see also this post).