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