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AMS Metabolite Profiling Studies

• Metabolite Profiling is one of the essential tools in drug development.
• Regulatory authorities have provided substantive reasoning and guidance for the conduct of metabolite profiling studies.

AMS metabolite profiling is an essential tool in the drug development instrumentation arsenal with its sensitivity and specificity in the detection of 14C. Metabolites undetected in pre-clinical animal studies, and metabolites unique to humans, are readily detected and quantitated using 14C-labeled drug product.

Accium BioSciences has successfully delivered on a wide range of AMS-based metabolite profiling studies. Each study is customized to address particular challenges specific to each program. An outline of the various approaches we have employed in the design and conduct of these studies is shown below:

Typical Clinical Design

    • Enroll six to eight subjects.

    • Can be a standalone metabolite study or easily combined with a mass balance or absolute bioavailability study.

    • Radiolabeled dose as low as 100 nCi.

    • Collect 1-2 mL plasma for AMS pharmacokinetics and metabolite profiling.

    • Collect urine and feces if profiling those matrices.

Bioanalytical Design

Pre-study Phase

• Transfer extraction and HPLC procedures to Accium.
• Transfer unlabeled parent drug and any metabolites, if available, as reference standards.
• Demonstrate acceptable chromatography conditions by UV-HPLC (using spiked references).

Study Phase

    • Prepare and analyze all samples by AMS to obtain total 14C plasma.

    • Accium Study directors work together with your team to select the time points of interest for metabolite profiling based on the total 14C results.

    • Prepare pools across subjects at Client-selected time points (typically four to six time points).

    • Extract pools, spike unlabeled drug reference(s), HPLC and collect relevant fractions.

    • Prepare and analyze each HPLC fraction by AMS.

    • Provide final profile data, customized to the Clients requirements.


• Radiolabeling permits detection of all known and unknown 14C-metabolites.
• Reduction of isotope to nCi range eliminates dosimetry requirements.
• Ultrasensitive AMS analysis can definitively quantify the appearance of unique metabolites.