Human Carbon-14 AME Studies Services - Isotope Science / Alfa Chemistry

Our Human Carbon-14 AME Studies Services

We provide end-to-end solutions for human carbon-14 AME studies, including:

Synthesis of Human-Ready Carbon-14 Radiolabeled Compounds

Mass Balance Studies

Metabolite Profiling and Identification

High-Radioactivity Dose Pharmacokinetics

Our Services

Synthesis of Human-Ready Carbon-14 Radiolabeled Compounds

Our team specializes in synthesizing high-purity, human-ready carbon-14 labeled compounds tailored to specific drug candidates. We ensure that these compounds meet regulatory standards for clinical use.

Mass Balance Studies

We conduct comprehensive mass balance studies. These studies determine the total recovery of radioactivity in biological samples. This provides an essential overview of the drug's excretion routes, whether through urine, feces, or other excretory mechanisms.

Metabolite Profiling and Identification

Using advanced analytical techniques, we identify and characterize drug metabolites, ensuring thorough metabolic profiling. It may include 14C total radioactivity ultrasensitive measurement by accelerator mass spectrometry (AMS), metabolite profiling and quantitation by LC-AMS and LC-MS/MS, and metabolite identification (MetID) with high-resolution mass spectrometry (HRMS) and NMR.

High-Radioactivity Dose Pharmacokinetics

For drugs requiring high-sensitivity pharmacokinetic evaluation, we conduct studies using higher doses of radiolabeled compounds, ensuring accurate and reliable data.

Applications of Human Carbon-14 AME Studies

AME studies have diverse applications across various stages of drug development:

Early Drug Development: Radiolabeled AME studies provide critical insights into the drug's ADME properties, informing dose selection and safety assessments during early clinical trials.

Metabolite Safety Assessment: These studies help identify human-specific metabolites, which are essential for understanding safety implications and designing further toxicological evaluations.

Bioavailability and Bioequivalence: AME studies allow for precise quantification of drug absorption and bioavailability, aiding in the evaluation of generic formulations or alternative delivery methods.

Regulatory Submissions: Data from AME studies is often required by regulatory agencies to address pharmacokinetics, metabolism, and safety concerns, ensuring smooth approval processes.

Regulatory Guidance

Our human carbon-14 AME studies adhere to global regulatory standards, including guidelines from:

U.S. Food and Drug Administration (FDA) Guidance
Safety Testing of Drug Metabolites
ICH M3(R2) and S9 Guidelines
European Medicines Agency (EMA) DDI
Pharmaceuticals and Medical Devices Agency (PMDA) in Japan
Guidelines for Industry Safety Testing of Drug Metabolites" (MIST) of China National Medical Products Administration (NMPA)
…

Why Partner with Us?

Integrated Expertise: Our multidisciplinary team combines expertise in radiochemistry, pharmacokinetics, and analytical chemistry, ensuring the highest level of technical proficiency.

Regulatory Alignment: Our services are designed to meet and exceed regulatory requirements, ensuring a seamless transition from research to clinical development.

State-of-the-Art Facilities: We employ cutting-edge technology and equipment to provide accurate and reliable results. Our facilities are compliant with regulatory standards.

Tailored Research Solutions: We provide customized research solutions that align with our clients' specific needs, enhancing the development process.

By leveraging our specialized services, cutting-edge technologies, and deep regulatory knowledge, our human carbon-14 AME studies empower pharmaceutical companies to make informed decisions, accelerate drug development, and meet stringent global standards. Contact us today to learn how our solutions can support your next breakthrough in drug development.

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

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