Guidance for Industry No. 207: Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals. Marker Residue Depletion Studies to Establish Product Withdrawal Periods. VICH GL48(R).

摘要

As part of the approval process for veterinary medicinal products in food-producing animals, national/regional regulatory authorities require data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible tissues including meat, milk and eggs. The objective of this guidance is to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This guidance is one of a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the VICH regions.