Application Of Low Energy Accelerator Mass Spectrometry In Radiolabeled Absolute Bioavailability (F ; hABA) Studies
Poster Authors:
Victor Kariuki, Phillip Atkins, Stephen English
Pharmaron, 20340 Seneca Meadows Parkway, Germantown, MD, 20876, USA
Radiolabeled ADME Bioavailability
Measuring absolute bioavailability in early clinical development has typically required a separate intravenous toxicology program until recently. A two-part study design combining mass balance data with absolute bioavailability (F; hABA) in a single program has facilitate richer pharmacokinetic (PK) datasets to be generated.
About this Poster
At WRIB 2026, Pharmaron scientist Victor Kariuki presented validated methods that make this approach more accessible. This work focuses on Low Energy Accelerator Mass Spectrometry (LEAMS), a technology that delivers the sensitivity required for radiolabeled bioavailability work with less complexity than conventional AMS.
Capabilities
The poster presents the first reported hABA assays developed and validated on LC+LEAMS technology. Pharmaron validated two distinct assays in full alignment with ICH M10 bioanalytical method validation standards across twelve analytical runs.
Key areas covered in the poster include:
- LLOQ performance and calibration range across both assays
- Accuracy, precision and carryover results
- A carbon carrier innovation that significantly reduces required carbon mass compared to traditional AMS sample prep
The data makes a practical case for LEAMS as a regulatory-compliant option for hABA work to fit directly into existing early clinical development timelines.
Why This Matters for Your Program
Programs that generate absolute bioavailability data alongside mass balance ADME data early gain a clearer picture of how a drug behaves before larger trials begin. That reduces uncertainty and supports more confident regulatory interactions.
The validated LC+LEAMS pathway described in this poster supports that goal with methods designed to meet ICH M10 expectations and handle the sensitivity demands of radiolabeled microdose IV studies.
Get the Full Poster
The complete WRIB 2026 poster includes full calibration tables, QC datasets, validation summaries and the carbon carrier methodology.
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