Skip to main content
. 2006 Oct 10;8(4):8.

Figure 5.

Figure 5

Mean area under the time-concentration curves of tacrolimus and pimecrolimus in animal and human studies. International Conference on Harmonisation (ICH) Guidelines: Maximum recommended human dose (MRHD) (highest mean exposure) of 25 times or greater represents an adequate safety margin. In murine toxicology studies, no malignancies were observed with exposure to tacrolimus ointment 0.03% at 10 times the MRHD; at 26 times the MRHD, lymphoma was seen with tacrolimus ointment 0.1%.[12,37,57] NOAEL = no observed adverse-effect level; LOAEL = lowest observed adverse-effect level.