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ADME and Metabolite Identification

Identification of metabolites is accomplished at different stages of the drug development process and both, in vitro- and in vivo- methods are employed. In vitro studies normally use liver microsomes, liver slices or hepatocytes from animals and humans and generally should be conducted before initiation of clinical trials. In vivo metabolism study results in non-clinical test species generally should be available early in drug development, and their results will either confirm the results obtained from in vitro studies or reveal quantitative and/or qualitative differences in metabolism across species. In their guidelines Safety Testing for Drug Metabolites the FDA specifically adresses safety concerns that may arise from this situation. Consequently the guidelines encourage the identification of differences in drug metabolism between animals used in non-clinical safety assessments and humans as early as possible in the drug development process. This is also in the interest of the sponsor as discovery of disproportionate drug metabolites late in drug development can potentially cause development and marketing delays.

Metabolite testing and bioanalysis are two sides of the same medal and modern interpretation of the Industry Guidelines calls for a close interface bewteen metabolite evaluation and bioanalytical studies. At SBA we have reacted to this prevailing view. Even though closely linked, metabolite ID and bioanalysis require very different skill sets and different instrumentation. At SBA we offer a complete package for your ADME studies and assessment of metabolites at early stage. Our services comprise targeted and non-targeted strategies for metabolic profiling and state-of-the-art techniques for metabolite identification, including accurate mass analysis using a Thermo Scientific OrbitrapTM. Please contact us for more information or a quote for the following services:    

  • Method development and validation
  • Metabolic Profiling
  • 14C Analysis
  • Total Radioactivity Balance
  • Identification of Metabolites


Please see here some recent publications that we have published together with clients:

Disposition and Metabolism of Setipiprant, a Selective Oral CRTH2 Antagonist, in Humans. www.ncbi.nlm.nih.gov/pubmed/24214422

Elucidation of the Metabolic Pathways and the Resulting Multiple Metabolites of Almorexant, a Dual Orexin Receptor Antagonist, in Humans. www.ncbi.nlm.nih.gov/pubmed/23431113