Metabolite Profiling Using AMS
Metabolite Profiling Using AMS Services
Pharmaron knows it is essential to understand the fate and structure of metabolized compounds early in the research and development process because it is vital for lead compound design in the discovery and safety assessment stages.
Our team of world-leading experts helps our partners conduct microtracer human metabolism studies using many metabolite profiling strategies to help advance drug discovery programs. In addition, our team can advise on the use of AMS to deliver valuable metabolism data after a traditional (macrotracer) dose study, where conventional methods are not sufficient to meet these endpoints.
Fully quantitative metabolite profiling combines uHPLC fractionation, followed by AMS analysis of the LC fractions. Our team conducts metabolite profiling by LC+AMS once the routes and rates of excretion are established to address metabolite safety in human (FDA, MIST).
Metabolite Profiling Strategies
- uHPLC metabolite profiling methods are initially transferred and verified
- Profiling in plasma across subjects/timepoints (typically AUC pools) or individual pools per subject
- Profiling in urine and fecal homogenates across subject/timepoints
- LC+AMS radio-profiling generates fully quantitative data for each matrix to characterize all observed human metabolites
- Metabolite identification for any unknown metabolites is conducted by HR-MS
- Metabolite profiling can also be conducted in bile, CSF, specific tissue or cellular fractions (i.e. PBMCs)
Advantages of Working with Our Team of Experts
- State-of-the-art HRMS
- Biotransformation specialists and successful application of FDA “MIST” guidelines
- Supports integrated non-clinical and clinical 14C metabolism programs
- Full project management supporting multi-site metabolism development programs