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.

Learn More: Clinical Development Services Overview

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