Non-clinical ADME with Radiolabelled Compounds

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Non-clinical ADME with Radiolabelled Compounds Services

The use of radiolabelled compounds is the primary tool for understanding metabolism and conducting non-clinical ADME studies. By radiolabelling a test compound, our team can follow its metabolism and ensure that we do not miss any metabolites in the biotransformation pathway. When partnering with Pharmaron, our team employs state-of-the-art technology to generate key quantitative and qualitative data to advance R&D programs. 

Pharmaron conducts a wide range of non-clinical ADME studies. These investigations are typically performed in the appropriate toxicology species, but also can be extended into a wide range of pharmacology and disease models. Our team also offers AMS technology to support ultra-sensitive quantitative analysis of 14C-compounds when LSC has insufficient sensitivity.

A person with long dark hair, wearing a white lab coat and purple gloves, is using a microscope in a laboratory. The person is focused on adjusting the microscope while conducting preclinical ADME studies, and laboratory equipment is visible in the background.

Non-clinical ADME Capabilities

  • in vitro/in vivo metabolism & PK studies with 14C and 3H
  • Total [14C] or total radioactivity (TRA) analysis of blood, plasma, excreta (mass balance), met profiling and met id
  • Quantitative tissue distribution studies with QWBA, including human dosimetry in albino and pigmented animal models
  • Rapid imaging with novel digital ‘real-time’ autoradiography 
  • Cellular distribution studies with mARG
  • in vitro comparative species metabolism studies in hepatocytes/microsomes
  • in vitro DDI studies: enzymes, transporters
  • Plasma protein binding and blood/plasma partitioning ratios
  • Tissue disposition of 14C/3H radiolabelled biologics in target organs and tissues of interest
GMP Radiosynthesis | human AME hAME

Radiosynthesis

  • Standard 14C and 3H radiosynthesis to provide radiolabels for non-clinical ADME
  • GMP preparation of 14C-drug substance and 14C-drug product for clinical ADME
  • Non-GMP clinical-grade re-purification of 14C-drug substance for AMS-enabled human microtracer studies
  • 14C and 3H radiolabelling of large molecules and biologics e.g. oligonucleotides, peptides, proteins
  • Expert metabolism and biotransformation advice for positioning the radiolabel so that it is in a metabolically stable part of the molecule