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Metabolite Profiling & Identification

Determining metabolite formation early on is key to predicting a potential liability and preventing costly delays further down the development pipeline. Metabolite Identification (Met ID) services at the Laboratory Testing Division support projects from early discovery through NDA submission, and are conducted using both in vitro and in vivo systems to identify soft spots and set the stage for success in human trials. Using advanced LC-MS-based techniques for metabolite profiling and structural identification, the Met ID team works in tandem with the entire DMPK unit to provide the information you need to take your compound from concept to candidate.

Early-Stage Met ID
+ Identify soft spots & reactive metabolites to optimize lead compounds
+ Discover the pathway toward metabolite identification
+ Mitigate potential metabolite liability in drug development

Preclinical Development Stage Met ID
+ Understand drug-drug interactions and drug safety profiles for subsequent toxicology studies
+ Predict whether toxicological findings observed in preclinical studies are likely to replicate in humans
+ Compare metabolism across species to make accurate predictions for clinical trials

NDA Stage Met ID
+ Learn where the potential metabolites will reside and how they will behave in humans (hAME studies)
+ Determine quantitative metabolite levels in humans
+ Discover how a compound is metabolized and where it will be excreted
+ Compare quantitative profiles to preclinical toxicology species (MIST guidance)