EMA Guidelines on Metabolism Studies Effective Feb 2012
Posted on Mon, Feb 20, 2012 @ 01:00 PM
Metabolism & Residue Kinetics of Veterinary Drugs in Food-producing Animals
Veterinary medicines have an important role in the control of disease and prevention of animal suffering but also have the potential to cause harm if incorrectly used. Statutory controls have therefore been established to protect consumers from the effects of harmful residues of these medicines in their food.
EMA Guidelines on Metabolism
Recent guidelines on veterinary medicines issued by the EMA, VICHGL46 (Metabolism in Food Producing Animals), VICHGL47 (Comparative Metabolism Studies) and VICHGL48 (Residue Depletion Studies) are effective this month and highlight the need to determine the identity of metabolites in edible tissues obtained from farm animals.
Environmental Fate Studies on Veterinary Medicines
Veterinary medicines may also distribute into the environment following administration to the animal as the majority of the drug is usually eliminated from the animal in excreta. Risk assessments may trigger environmental fate studies for the medicine, in which case it is important to know the structure of the residues or metabolites formed in these studies.
Metabolite Identification of Low Concentration Residues
The major challenge in identifying metabolites and/or degradation products in environmental fate or residue studies is the low concentration of components of interest especially compared to the high concentrations of endogenous material. The key to success is therefore based on optimal separation and detection of components.
At Quotient we have addressed these needs by investment in low level counting technology (TopCountTM) and fraction collection systems for quantification of radioactive components, whilst metabolite identification is assisted by the accurate mass capability provided by the Thermo Orbitrap LC-MS/MS. Where reference standards are not available, in vitro techniques can be employed to generate metabolites that can be used for structural analysis.
For more information about metabolite identification techniques used at Quotient, request our Fact Sheet
