For estradiol levels, the purpose of the study was to determine the residue levels in the treated animals and compare them to the allowable incremental increases permitted under 21 CFR 556.240. The results are shown in Table 3. The results of the estradiol assays from the treated and control animals were compared to the allowable incremental increases permitted under 21 CFR 556.240. When the residues of estradiol in the treated animals were compared to the naturally occurring levels in the untreated controls they were found to be much lower than the allowable incremental increases. 125 ppt, and, as such, the statistical significance of these observed differences also cannot be determined.
Values are less than the LOQs for the respective tissues.
The approval of this change is not expected to have any adverse effect on the safety or effectiveness of these new animal drugs. Accordingly, this approval did not require a reevaluation of the safety and effectiveness data in the parent application.