AMS Services for Drug Metabolism

Pharmaron’s Accelerator Mass Spectrometry AMS Services for Clinical and Non-clinical Drug Metabolism

Accelerator Mass Spectrometry (AMS) is an ultra-sensitive tool that measures trace amounts of radiolabeled compounds in clinical and non-clinical drug metabolism studies. Pharmaron’s AMS services are designed to support ADME, absolute bioavailability, pharmacokinetics, toxicokinetics, metabolite safety and metabolite profiling studies. AMS data assists drug development teams in generating high-quality quantitative data when other detection technologies such as LSC or LC-MS/MS cannot reach the necessary sensitivity.

AMS can be particularly valuable for compounds with low systemic exposure, long half-lives, low-dose study designs, or complex matrices, as the technique is described in the source document as having no matrix interference or ionisation issues and being 500 to 10,000-fold more sensitive than traditional LSC or LC-MS/MS methods.

Key AMS Services and Takeaways for Drug Metabolism Studies:

• Ultra-sensitive ¹⁴C analysis for clinical and non-clinical studies: Pharmaron’s AMS services support trace-level detection and quantification of ¹⁴C atoms for clinical and non-clinical drug metabolism applications, including ADME, PK, TK, MIST, absolute bioavailability, and metabolite profiling.
• Integrated support for hADME and absolute bioavailability: IVPK studies, Human ADME and absolute bioavailability IVPK approaches can be run in parallel in the clinic to generate a deeper understanding of drug metabolism, systemic PK, clearance, volume of distribution, and biotransformation.
• Broad sample type compatibility: plasma, blood, urine, faeces, bile, CSF, expired air, tissues, and PBMCs as compatible sample types for AMS analysis.
• High-resolution metabolite profiling using LC+AMS: Pharmaron’s AMS capabilities include LC+AMS for high-resolution metabolite profiling and quantitation of ultra-low-level metabolites.
• Regulatory-ready study support: Pharmaron provides GCP-compliant support for FDA, EMA, MHRA, JMHW, and TSA submissions, with 21 CFR Part 11 compliant software, audit trail, and automated workflows for Ionplus AMS.

Where sensitivity, low dose radiolabelled study designs or detailed metabolism data are important for your drug development program, AMS may offer a robust path to defensible decision-making for both clinical & non-clinical metabolism studies.

Why Pharmaron?

Pharmaron’s AMS services combine more than 25 years of experience with world-class AMS facilities in the US, UK, and China.

We can run complete end-to-end integrated ¹⁴C metabolism studies, from radiosynthesis through non-clinical and clinical work packages. This allows us to streamline study coordination and shorten study timelines. Radiosynthesis is performed on our Ionplus 50kV LEA low energy gaseous ¹⁴CO₂ AMS rapid sample analyser or our NEC 250kv ultra-sensitive SS-AMS that analyses graphite ¹⁴C samples. Both AMS machines feature dual ion sources and the capacity to analyse over 2,000 samples per week.