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  4. CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals
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GUIDANCE DOCUMENT

CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals September 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-8229
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The human food safety evaluation of veterinary drug residues helps ensure that food derived from treated food-producing animals is safe for human consumption. As part of the data collection process, studies should be conducted to characterize the metabolites to which laboratory animals are auto-exposed during the toxicological testing of the veterinary drug. The purpose of these studies is to determine whether the metabolites that people will consume from tissues of target food-producing animals are also produced by metabolism in the laboratory animals used for the safety testing. It is understood that, if the laboratory animals produce substantially similar metabolites as those produced by the food-producing animal, the laboratory animals will have been auto-exposed to the metabolites that humans will consume from tissues of treated food-producing animals. Auto-exposure of metabolites will ordinarily be taken as evidence that the safety of metabolites has been adequately assessed in the toxicology studies.

The objective of this guidance is to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary drugs produced by laboratory animals.

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All written comments should be identified with this document's docket number: FDA-2010-D-8229.

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