Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing [open pdf - 262KB]
"The current guidance is one of a series of guidances developed to facilitate the mutual acceptance of safety data necessary for the determination of acceptable daily intakes (ADIs) for veterinary drug residues in human food. This guidance was developed after consideration of the current practices for evaluating veterinary drug residues in human food in the EU, Japan, USA, Australia, New Zealand, and Canada. It also took account of available data from sub-chronic and chronic toxicity studies. While this guidance recommends the framework for chronic toxicity testing of veterinary drugs, it is important that the design of the test remains flexible. This guidance does not preclude the possibility of alternative approaches that may offer an equivalent assurance of safety, including scientifically based reasons as to why chronic toxicity testing may not need to be provided. Within the context of this guidance, tests should be tailored to adequately establish the dose-response relationship and a no-observed adverse effect level (NOAEL) for toxicity seen following chronic treatment. Adequate toxicity testing should include the administration of repeated doses to assess the effects of prolonged exposure to a parent compound and/or metabolites, to define the toxic effects of compounds following chronic exposure, and to ascertain the highest dose that does not produce toxicity. All available information on the compound should be utilized in designing the chronic toxicity test. The data obtained in this test may be used to establish a NOAEL for a veterinary drug."
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