EMA publishes updated VICH guidance on metabolism and residue kinetics studies

The EMA has published two revised VICH guidelines, relating to “Studies to Evaluate the Metabolism and Residues Kinetics of Veterinary Drugs in Human Food-producing Animals”:

1.      VICH GL48: Marker Residue Depletion Studies to establish Product Withdrawal Periods

2.      VICH GL49: Validation of Analytical Methods used in Residue Depletion Studies

Both guidelines will come into effect as of January 2016.