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Discovery and Basic Research
Partner Presentation

LC–MS Strategies for Metabolite Identification in First-In-Human (FIH) Studies | Hybrid Bioanalysis of siRNA Antisense and Sense Strands

Tuesday, November 11, 2025
2:00 PM - 3:00 PM CT
Location:360 Stage #4, Exhibit Hall

Sponsored By 
Discovery and Basic Research Partner Presentation DBR

To find all circulated metabolites (LC-UV/MS) and estimate the exposure for the major circulated metabolites in human plasma from First in Human (FIH) study based upon LC-UV/MS.
Systematic approach is the key for exploring the known and unknow metabolites, and method optimization using in vitro and in vivo samples are also very critical.
The higher UV wavelength (≥300 nm) obtained by PDA can be used to estimate the percentage of major metabolite (>10% of total) in plasma from First in Human (FIH) study based on the FAD MIST guidance.
Inclusion-list approach is approved to be an approach systematically finding the unknown and known metabolite with assistance of software (such as Sciex Molecule Profiler);
EAD technology also is approved to best way to get the location of the glucuronide and other conjugation.

Learning Objectives:

  • Systematic approach is the key for exploring the known and unknow metabolites, and method optimization using in vitro and in vivo samples are also very critical.
  • The higher UV wavelength (≥300 nm) obtained by PDA can be used to estimate the percentage of major metabolite (>10% of total) in plasma from First in Human (FIH) study based on the FAD MIST guidance.
  • Inclusion-list approach is approved to be an approach systematically finding the unknown and known metabolite with assistance of software (such as Sciex Molecule Profiler);
  • EAD technology also is approved to best way to get the location of the glucuronide and other conjugation.