Non-radiolabeled Study to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals and Anti-doping Analysis in Equine Sports: Application of High-Resolution Mass Spectrometry

Abstract

The chapter will discuss an alternative approach to conduct the metabolism and residue kinetics of veterinary medicine for food-producing animals using high-resolution mass spectrometry in a non-radiolabeled study under the scope of VICH GL46. Section 1, Introduction, will give an overview of high-resolution mass spectrometry, metabolism and residue studies as well as general requirements for traditional radiolabeled metabolism and residue kinetics studies. Limitations of conducting a radiolabeled residue study will also be discussed. Sections 2 and 3 will review the techniques of non-radiolabeled (cold) metabolite profiling/identification with high-resolution mass spectrometry (various data acquisition functions, data mining tools and the semi-quantitative and quantitative methods for metabolites. Section 4 presents two case studies where high-resolution mass spectrometry was used for the marker residue and marker to total residue ratio determination in residue studies for gamithromycin in sheep and ciclesonide in horses. Section 5 summarizes the advantages and disadvantages of the high-resolution mass spectrometry technique and future perspectives for the use of high-resolution mass spectrometry in other fields of veterinary drug development.