Integrated 14C Human ADME

Pharmaron specializes in integrating all elements of an entire metabolism program for drugs in clinical development. This includes optimal strategies for radiolabelled synthesis, design and conduct of 14C clinical studies and in-depth analytical support for parent drug and metabolite analysis including structure elucidation. These clinical studies are supported by related non-clinical studies.

Integrated 14C clinical study designs include:

  • Radiolabelling strategy to achieve the desired recovery and metabolism endpoints
  • Micro- and macro-tracer ADME approaches to achieve study specific goals, optimize time and subject exposure
  • Mass balance and metabolism to address MIST guidance
  • Hybrid 14C analysis employing co-calibrated LSC and AMS analytical methods to conserve time and optimize sensitivity
  • Separate IV-PK microtracer studies to determine absolute bioavailability
  • in vitro drug-drug interaction, microsomal and hepatocyte studies
  • in vivo animal ADME studies in toxicology species
  • QWBA and dosimetry assessments

Our team of analytical scientists provide extensive radioanalytical and chemical analyses:

  • NMR, MS and radio-chromatography to support radiosynthesis and ensure the highest quality 14C-API
  • LSC and AMS analysis for total radioactivity, optimally coordinated to each study
  • Parent and 14C parent compound by LC/MS and LC-AMS
  • Metabolite profiling by LC-RAD, LC-TopCount®, LC-AMS fraction collection and analysis
  • Metabolite identification by HRMS for human and preclinical samples

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