Early ADME in Phase 1 with BioMICADAS™

Use of low radiation ADME enables earlier, faster human knowledge with unparalleled accuracy using very small quantities of radiolabel.

In addition, Vitalea offers the following hybridized approach to ADME where we cover the full range of 14C concentrations using AMS and Liquid Scintillation Counting. Our scientists have many years of experience in merging the two platforms to deliver seamless results and cost efficiencies to our sponsors.

A low radiation, therapeutically relevant ADME study performed in Phase 1 testing maximizes value by delivering key human knowledge early and reliably, indicating human-specific issues at an early phase of development. This is only possible through the extreme sensitivity of the BioMICADAS™ Accelerator Mass Spectrometer (AMS), which provides sensitivity 10,000 greater than prior methods for ADME studies.

[Combining LSC and AMS]
Using LSC (traditional radiometric analysis) and AMS together can extend the range of experiments, guarantee adequate sensitivity and maximize efficiency, where high levels are necessary.

Key Information Obtained Early

  • Absorption
  • Metabolite burden
  • Unique human metabolites identified
  • Human - Safety Species correlation
  • Routes of excretion
  • Protein binding

Delivers Quickly and Cost Effectively

  • Low radiation (nanoCi) dose minimizes dosimetry concerns and formulation complexity
  • Fast approvals
  • Confirm or select proper safety species based upon human-animal metabolism correlations
  • Minimal method development
  • Obviate larger and later stage ADME Studies
  • Set better starting doses for Phase II
  • Select a better compound based upon results

Delivers the Human Component of FDA (MIST) Guidance

A significant application for AMS in early ADME studies is to establish knowledge of human metabolites and physiochemistry in relation to safety species. Vitalea enables human ADME to be performed with accuracy and precision in a cost-effective model, meeting FDA guidance expectations - "Metabolites in Safety Testing" (2008).

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