VICH GL54 Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD) - Scientific guideline

This document addresses the nature and types of data that can be useful in determining an acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.

Keywords: VICH, acute reference dose

Current effective version

VICH GL54 studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD)

Adopted Reference Number: EMA/CVMP/VICH/699251/2010 Summary:

The current guideline addresses the nature and types of data that can be useful in determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.

Document history

Draft VICH GL54: Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish an acute reference dose (ARfD)

Draft: consultation closed Consultation dates: 20/03/2015 to 15/08/2015 Reference Number: EMA/VICH/699251/2010 Summary:

The current guideline addresses the nature and types of data that can be useful in determining an acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.