Bioequivalence and Bioavailability Forum

Hi Simon,

❝ Further more I'm not sure what you would mean my Cmax2 and Tmax2; there can only be one maximum...

Haha, „There can be only one” of the Highlander? For multiphasic or pulsatile MR products the EMA wants a pre-specified cut-point for the AUC (like the FDA does). So far, so good.
In its eternal wisdom the EMA wants not only the (global) C_max but also the C_max within each interval (GL Section 6.8.1.1).

@Robin: Trivial in Phoenix. Perform NCA on the entire data set (PHX will do the interpolation of pAUCs if actual times ≠ scheduled times). Split the original data set by the cut-off time (scheduled, not actual time). Run NCA on both (deselect everything except C_max and t_max). Rename C_max to C_max1, C_max2. Join or merge the results.