Guidance for Industry No. 208: 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).

摘要

This guidance document is intended to provide a general description of the criteria that have been found by the European Union (EU), Japan, United States of America (USA), Australia, New Zealand and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies. During the veterinary drug development process, residue depletion studies are conducted to determine the concentration of the residue or residues present in the edible products (tissues, milk, eggs or honey) of animals treated with veterinary drugs. This information is used in regulatory submissions around the world.