We use modeling of radiation exposures to support human absorption, metabolism, and excretion (hAME) clinical trials of radiolabeled molecules.
Dosimetry scientists use preclinical tissue distribution data to calculate dosimetry parameters in conjunction with applicable regulations and guidelines that govern human dosimetry, including the International Commission on Radiological Protection (ICRP), the US Food and Drug Administration (FDA), and the World Health Organization (WHO).
Our scientific team determines a safe radioactive dose level to be administered during the human radiolabeled mass balance and pharmacokinetic (PK) study.
The radioactive dose level and calculated radiation exposures to individual tissues and the whole body may be submitted to institutional review boards and ethics committees across the US and Europe for approval to conduct a human radiolabeled clinical study.
All in vivo metabolism studies are performed in our AAALAC accredited facilities where we value animal welfare as our highest priority, creating a culture of care, supporting the 3Rs.