The risk assessment of bound residues of veterinary drugs

S.D. Brynes; N.E. Weber

The risk assessment of bound residues of veterinary drugs

In: Residues of Veterinary Drugs and Mycotoxins in Animal Products

Authors:

S.D. Brynes

S.D. Brynes Center for Veterinary Medicine, United States Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855 USA

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N.E. Weber

N.E. Weber Center for Veterinary Medicine, United States Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855 USA

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Type:: Chapter

Pages:: 16–24

DOI:: https://doi.org/10.1163/9789004684171_004

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Summary

Covalently bound residues of veterinary drugs have presented significant problems for sponsors seeking registration and for regulatory scientists who must assess their risk. This paper outlines the approaches to the risk assessment of bound residues developed by the U.S. Food and Drug Administration (FDA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Both the FDA and JECFA have proposed approaches to the evaluation of bound residues that are similar. That is, both organizations initially rely on bioavailability studies, which are then followed with in vitro and in vivo studies as appropriate. Neither organization delineated follow-up tests, concluding that each bound residue will be evaluated on a case-by-case basis. To promote discussion, this paper proposes a 3-step approach to the risk assessment of bound residues that includes provision of a 10-fold safety factor based on a bound residue’s bioavailability and releasability.

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Residues of Veterinary Drugs and Mycotoxins in Animal Products

New Methods for Risk Assessment and Quality Control

E-Book ISBN:: 9789004684171

Publisher:: Wageningen Academic

Print Publication Date:: 01 Jan 1996

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- Life Sciences

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The risk assessment of bound residues of veterinary drugs

Summary

Citation Info

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Residues of Veterinary Drugs and Mycotoxins in Animal Products

New Methods for Risk Assessment and Quality Control

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