Human AME studies aim to characterize any circulating metabolites greater than 10% of the AUC (area under the curve) of drug-related material and more than 80% of the recovered radioactivity from excreta.
Conduct hAME studies earlier, especially if there are any possible toxic metabolites or metabolites that may be unique to humans compared to animals, and/or if you need to establish early information regarding major metabolites and excretion patterns in order to plan future study designs.
hAME studies are not typically conducted after Phase II of a clinical trial.
The hAME team consists of nuclear pharmacists, radiation safety committee members, medical doctors, and DMPK scientists working with sponsors and clients to develop customized study designs that follow requirements from global regulatory authorities [e.g., FDA (including MIST, ICH) and EMA].
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.
