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AOAC/Elanco Extend Contract to Evaluate Additional Veterinary Drug Residues
AOAC has signed an extension to its current contract with Elanco Animal Health, A Division of Eli Lilly and Co., to perform independent, third-party evaluation and validation of fit-for-purpose tissue residue methodology for the determination of animal health drugs. Under the modified contract, AOAC will hold expert review panels (ERPs) to critically evaluate and recommend candidate methods for avilamycin, nicarbazin, and apramycin. The goal is to update and modernize methodology that is fit-for-purpose, globally accepted, and meets regulatory testing requirements.
Under the original contract with Elanco Animal Health and with AOAC guidance, candidate methods were developed for the initial five compounds of high interest identified by the Stakeholder Panel on Veterinary Drug Residues in October 2008. Expert Review Panels (ERPs) evaluated the most promising methods and recommended candidate methods for the analyses of tylosin, tilmicosin, narasin, monensin, and ractopamine in animal tissues. International participation on the stakeholder panel and ERPs was critical in ensuring that methods are accepted worldwide and meet regulatory testing requirements.
Currently, AOAC has developed fitness-for-purpose statements and issued a call for tissue residue methods for avilamycin, nicarbazin, and apramycin. The methods assembled will be reviewed by an ERP (tentatively scheduled for fall 2010) at AOAC Headquarters in Gaithersburg, Maryland, USA. A candidate method for each drug will be selected by the ERP for further evaluation and validation (single laboratory and multilaboratory), with the ultimate goal of updating and modernizing methodology that is recognized worldwide and meets regulatory testing requirements.
For more information, contact Bob Rathbone, senior director, publications and methods validation, at rrathbone@aoac.org. Full coverage is scheduled for the July/August issue of Inside Laboratory Management.
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