The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements for drugs intended for using in aquatic food-producing species.

This document is an extension to the parent residue guidance: CVM Guidance for Industry (GFI) #207/VICH GL48, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods.” This guidance, VICH GL57, provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.

Metabolism studies based on CVM GFI #205/VICH GL46, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues,” can be used in aquatic food-producing species to identify a marker residue.

Questions?