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. 2006 Oct 10;8(4):8.

Figure 6.

Figure 6

Mean area under the time-concentration curves (AUCs) 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. No malignancies were observed in mice that were treated for 2 years with exposure to pimecrolimus at 45 times the MRHD in adult patients; at 77 times the MRHD, lymphoma was seen.[12,37,57] NOAEL = no observed adverse-effect level; LOAEL = lowest observed adverse-effect level.