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 - Scientific guideline

This document provides study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the requirements in the VICH regions.

Keywords: VICH, consumer safety, residues of veterinary drugs in human food, withdrawal periods

Current effective version

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

Adopted Reference Number: EMA/CVMP/VICH/463199/2009

Document history

VICH Topic GL48: at step 4: Guideline on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods

Draft: consultation closed Consultation dates: 10/12/2009 to 20/05/2010 Reference Number: EMEA/CVMP/VICH/463199/2009