CVM GFI #160 (VICH GL37) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
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Guidance Issuing OfficeCenter for Veterinary Medicine
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 repeat-dose (chronic) toxicity testing.
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.
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2003-D-0372.