A variety of toxicological evaluations are performed to establish the safety of veterinary drug residues in human food. The objective of this guidance is to establish recommendations for internationally harmonized 90-day repeat-dose testing.

The current guidance is one of a series of guidances developed to facilitate the mutual acceptance of safety data for the determination of acceptable daily intakes (ADIs) for veterinary drug residues in human food.

Although this guidance recommends a framework for 90-day toxicity testing of veterinary drugs, it is important that the design of the tests remain flexible. It is recommended that tests be tailored to adequately establish the dose-response and a no-observed adverse effect level (NOAEL) for toxicity following 90-day compound treatment.

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