Recorded: April 2023

This webinar showed the importance of clinical metabolite analysis and the analytical methodologies used to address the regulatory requirements.

Agenda

  • How can we increase confidence in prediction of human circulating metabolites for small molecules?w metabolism impact defines DMPK properties?
    • General overview of current industry thoughts and practices
  • Analytical techniques and Study Designs for Clinical Metabolite Profiling
    • Example of integrated study involving radiolabelled human ADME, including AMS, to identify major clinical metabolites
  • Clinical Metabolite Profiling
    • How do we develop a suitable chromatographic method for metabolite profiling in carbon-14 clinical studies?