Radiolabelled Carbon-14 Human ADME Services

Integrated Carbon-14 Clinical Studies
Analytical Support

Radiolabelled carbon-14 (14C) studies play a pivotal role in understanding the absorption, distribution, metabolism, and excretion (ADME) properties of pharmaceutical compounds, essential for drug development and regulatory submissions. Our company is a leading service provider in the life sciences industry with over 20 years of experience, specializing in offering comprehensive radiolabelled carbon-14 human ADME services.

Our Services

Our company excels in designing and executing radiolabeling strategies for pharmaceutical compounds. This includes optimizing the synthesis of radiolabels, ensuring they are located in metabolically stable positions within molecules. By employing both macrotracer and microtracer approaches, our company facilitates preclinical ADME/QWBA studies and conducts definitive 14C clinical studies.

Integrated Carbon-14 Clinical Studies

Integrated Carbon-14 clinical studies offer distinct advantages in compound development. They enable early identification of metabolites, elucidation of biotransformation pathways, and assessment of metabolite safety profiles.

Our company offers integrated Carbon-14 clinical studies in healthy volunteers, employing 14C hADME and 14C IV microtracers to determine absolute bioavailability (hABA). These studies utilize customized designs and consultation to address metabolites in safety testing. Our company's protocols, whether microtracer, macrotracer, or hybrid, optimize study parameters, conserving time and enhancing sensitivity.

Analytical Support

Our company provides in-depth analytical support for parent drug and metabolite analysis.

Total Radioactivity Analysis

Our company employs Liquid Scintillation Counting (LSC) and/or Accelerator Mass Spectrometry (AMS) for total radioactivity (total 14C) analysis. This analytical approach is instrumental in determining mass balance, elucidating excretion rates and routes, and quantifying overall drug exposure accurately.

Quantitative Metabolite Profiling and Identification

Our company excels in quantitative metabolite profiling using advanced analytical platforms such as LC-RAD and LC-AMS. These techniques allow for precise fraction collection and analysis, enabling the quantification of metabolites and facilitating comprehensive metabolite identification studies using High-Resolution Mass Spectrometry (HRMS).

Parent Compound Quantification and Stability Analysis

Our company's expertise extends to parent compound quantification using LC-MS/MS and LC-AMS, ensuring accurate measurement of drug levels in biological samples. Additionally, our company conducts stability assessments for 14C dose formulations, including compatibility studies, critical for maintaining the integrity and efficacy of radiolabeled drug products.

Radio-pharmacy Services and Documentation

Our company provides comprehensive radio-pharmacy services for 14C dose formulation and analysis, encompassing stability assessments and compatibility testing. We also offer meticulously documented synthesis and formulation reports for 14C-API (drug substance) and 14C dose formulations (drug product), accompanied by pharmacy manuals designed for submission to regulatory agencies such as the FDA under open IND applications, meeting stringent CMC (Chemistry, Manufacturing, and Controls) requirements.

Our company's radiolabelled carbon-14 human ADME services offer a comprehensive suite of solutions for drug developers, leveraging advanced techniques and regulatory compliance to support every stage of drug development. Contact us to learn more about how we can support your scientific endeavors and help you achieve your goals.

Trust Us for Your Clinical Research Needs.

Our company offers a comprehensive range of radiolabelled carbon-14 human ADME services to support a wide range of research and development efforts in the pharmaceutical, biotechnology, materials science and chemical industries.

Please kindly note that our products and services are for research use only.