Poster detailing the evolution of accelerator mass spectrometry for radiolabeled sample analysis in clinical research, with images and data charts.

Poster Authors:

Adrian Pereira and Marie Croft

Pharmaron UK Ltd, Hertford Road Hoddesdon Hertfordshire, EN11 9FH, UK

Revolutionizing Phase 1 Clinical Studies with AMS

Accelerator mass spectrometry (AMS) is now a cornerstone technology in early-phase clinical research, enabling the detection of trace levels of radiolabelled analytes like 14C in biological matrices. Once exclusive to radiocarbon dating, AMS is now integral to sample analysis for human ADME and bioavailability studies, offering unmatched sensitivity and operational efficiency.

What Is Accelerator Mass Spectrometry (AMS)?

AMS is a highly sensitive technique capable of quantifying 14C-labeled compounds at attomole levels in biological samples. It allows researchers to:

  • Detect minute radiolabelled drug concentrations
  • Trace metabolic pathways with extreme precision
  • Support microtracer studies with very low radiation doses

Its application has expanded across exploratory microdosing (Phase 0) and standard Phase 1 clinical trials for full ADME and IVPK profiling.

Why Use AMS for Radiolabelled Analysis?

AMS-Enabled Study Types

  • Microtracer ADME: Measures mass balance, recovery, and metabolite profiles
  • Microtracer IVPK: Determines absolute bioavailability (F) in a single-cohort setup
  • Parent drug quantification: Supports low-dose, high-accuracy assessments

AMS streamlines study designs by combining radiolabel and therapeutic doses in a single cohort, reducing timelines and subject exposure compared to traditional two-arm crossover trials.

Technological Evolution in AMS Systems

The evolution from bulky pelletron accelerators to Ionplus low-energy AMS systems has transformed clinical applications:

  • Compact footprint: From 250 m² (5MV tandem) to 12 m² (Ionplus LEA)
  • Faster sample processing and real-time interfacing
  • Regulatory-compliant software and user-friendly operation

These upgrades have increased AMS accessibility, allowing its integration into standard clinical sample analysis workflows.

Pharmaron’s AMS Capabilities

  • 350+ compounds analyzed using AMS
  • 160 Phase 1 trials supported since 2018
  • 4 AMS systems across three global labs
  • 70 drugs supported in FDA approvals

Pharmaron delivers rapid, validated AMS data tailored to regulatory expectations, supporting a wide range of compound types across various therapeutic areas.

References:

Discover how microtracer AMS can fast-track your clinical studies.

Learn more by reading our poster to learn how modern accelerator mass spectrometry can transform your radiolabelled clinical strategy. Reduce radiation, enhance sensitivity, and streamline data collection with confidence.