Non-clinical Studies Using Radiolabelled Compounds

The utilization of Accelerator Mass Spectrometry (AMS) in non-clinical studies is less common as high doses of [14C] in animal models are not restricted by the radiological safety concerns in humans. Hence, AMS-enabled non-clinical applications typically focus on potent compounds where doses in animal models are correspondingly low, requiring the exquisite sensitivity of AMS to generate quantitative and qualitative data.

AMS technology facilitates analysis of total 14C and 14C parent drug in a wide range of tissues/cells/biological fluids and AMS sensitivity requires only ultra-small (mg/µg) sample sizes. We also employ AMS in conjunction with HPLC/UPLC for metabolite profiling in all biological matrices.

Analysis is integrated with Pharmaron’s radiosynthesis capabilities for radiolabelling both small and large molecules with 14C.

Investigations:

  • IND-enabling preclinical metabolism and toxicology – ADME, toxicokinetics (TK), metabolite profiling
  • Target (proteins/cytokines) turnover studies
  • LC+AMS bioanalysis and total 14C for potent biologics (ADCs, oligonucleotides, fusion proteins, peptides)
  • Analysis of parent compound in a wide range biological matrices (i.e. plasma, skin, kidney, liver, spleen, CSF, bile, excreta)
  • Analysis of total 14C in all tissues/cells/biological fluids and expired air

 

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