Human radiolabeled absorption, metabolism, and excretion (human AME) studies provide:
- definitive information about mass balance and routes of elimination,
- a complete understanding of a drug's metabolism structure (including a comparison of human and animal metabolites to determine whether additional animal testing is warranted), and
- a determination of the ratio of parent drug to metabolite(s) in circulation.
In order to correctly identify hAME, our team of nuclear pharmacists, radiation safety committee members, medical doctors, and DMPK scientists work together with clients and sponsors to develop customized study designs that follow requirements from global regulatory authorities [e.g., FDA (including MIST, ICH) and EMA] for using a radiolabeled test compound. Merging scientific and regulatory components are critical to successful execution of a human AME study.
The ability to quickly analyze samples is key to a hAME study. In the United States, our shared campus in Wisconsin between the phase 1 clinical unit and the DMPK radioanalysis laboratory allows delivery of real-time radioanalysis results to manage subject-to-subject variability and facilitate timely subject release. In the UK, DMPK labs and clinical sites have hospital collaborations to successfully complete patient human AME studies in addition to normal healthy volunteers.
We've conducted more than 350 human AME studies, garnering decades of experience to guide successful study execution.