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J Vet Pharmacol Ther. 2006 Oct;29(5):345-53.

Qualitative assessment of human exposure to consumption of injection site residues.

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1
Pharmaceutical Development, Virbac S.A., 06511 Carros, France. asanquer@virbac.fr

Abstract

The recent adoption of the guideline on injection site residues in food producing animals by the Committee for Medicinal Products for Veterinary Use (CVMP) raised the question on the risk specifically related to injection site consumption. As noted in this guideline, residues at injection sites commonly deplete erratically. For the calculation of withdrawal time, treating residues at the injection site like those that occur in other tissues is questionable. An assessment of the risk related to the consumption of a whole or part of an injection site during a year was performed using a probabilistic approach. The risk assessment was modelled on the regimen of a 7-day antibiotic treatment, and was calculated on the scale of the European Union (EU) as a whole or of each European country. Our analysis indicated a maximal risk of 4 days of injection site consumption during a year in the EU. It also indicated that 37% of consumers would never eat an injection site in the same period. These results suggest that the risk of injection site consumption belongs more appropriately to an acute exposure risk than to a chronic one which is usually posed by the residues present in other edible tissues.

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