The chapter discusses 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. The application of high-resolution mass spectrometry for anti-doping analysis in horse racing is also briefly discussed. Section 1, Introduction, gives an overview of high-resolution mass spectrometry, metabolism and residue studies, and general requirements for traditional radiolabeled metabolism and residue kinetics studies. The limitations of conducting a radiolabeled residue study will also be discussed. Sections 2 and 3 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. The application of high-resolution mass spectrometry in anti-doping analysis and the study of the metabolism of steroids in racing horses is briefly discussed in Section 5. Section 6 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.
Part of the book: Equine Science