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Revised Guidance on Veterinary Drug Metabolism/Residue Kinetics


Federal Register Notice: FDA is making available a revised guidance for industry entitled Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies (VICH GL49(R). It provides minor updates to a final guidance on the same topic for which a notice of availability was published in the 9/15/11 Federal Register and has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. It is intended to provide a general description of the criteria that have been found by the European Union, Japan, U.S., Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies. To download this guidance, click here. To view this notice, click here.