International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies; Revised Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #208) 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)). This revised guidance, which provides minor updates to a final guidance on the same topic for which a notice of availability was published in the Federal Register of September 15, 2011, has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised VICH guidance document is intended to provide a general description of the criteria that have been found by the European Union, Japan, United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.