Clinical AME of Radiolabelled Compounds

Pharmaron offers comprehensive services to support a wide range of 14C radiolabelled studies in human (mass balance, metabolite profiling/MetID, DDI, absolute bioavailability (ABA) and PK). We are unique in providing fully integrated solutions for human clinical studies that includes radiosynthesis, clinical research, formulation and 14C analysis including AMS.

  • Pharmaron CPC (Clinical Pharmacology Center), Baltimore, MD
  • Pharmaron ABS (Advanced Bioanalytical Sciences) and AMS Laboratory, Germantown, MD
  • Pharmaron RLS (Radiolabelled Sciences): Radiosynthesis, Cardiff, UK & ADME/DMPK, Rushden, UK

We specialize in supporting clinical protocols for:

  • Metabolism –  Low 14C radioactive dose microtracer studies administering ~1 µCi of radioactivity compounded with a therapeutic mass dose
  • Bioavailability – Low 14C radioactive IV microdose studies administering ~1 µCi of radioactivity intravenously concomitant with a therapeutic mass dose (Clinical PK with Radiolabelled Compounds)

Ultra-sensitive AMS and HP(UP)LC+AMS analysis is utilized for quantitation of total radioactivity and 14C parent/metabolites for clinical metabolism and absolute bioavailability in Phase l microtracer and Phase 0 microdose studies conducted at our clinic in Baltimore or through our trusted network of third party clinical research providers.

Manufacture of 14C Radiolabelled Drug Substances and Drug Products for Clinical Studies

Phamaron's Radiolabelled Metabolism and PK Studies

Clinical PK with Radiolabelled Compounds Mass Balance with Radiolabelled Compounds Metabolite Profiling with Radiolabelled Compounds- Metabolite Safety Metabolite Identification by High Resolution MS (HRMS) Drug-drug Interaction (DDI) Studies

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