A Streamlined Approach To ¹⁴C Human ADME Studies

Regulatory requirements dictate that the absorption, distribution, metabolism, and excretion (ADME) of a new chemical entity (NCE) must be well understood before filing for a New Drug Application (NDA). Typically, human ADME studies are performed before the end of Phase II, but regulatory guidelines on metabolite safety encourage drug developers to consider doing them earlier, so that the development program is conducted with an understanding of how the drug is metabolized in humans. The entire human ADME process, from radiolabeling to clinical evaluation, can take up to 12 months and involve multiple vendors, which points to a need for a more streamlined approach.

Quotient Sciences is a leading provider of ¹⁴C-enabled drug development programs, having successfully conducted over 350 human ADME and other radiolabeled programs to date. The unique, integrated Synthesis-to-Clinic^® offering seamlessly delivers human ADME studies, from radiosynthesis of the ¹⁴C-labeled drug substance through all the required steps of the human study and the final clinical report, in a single, integrated program of work.

As well as conventional human ADME studies, where the radiolabeled dose is selected following appropriate dosimetry assessment, Quotient Sciences also offers microADME studies, where the radiolabeled dose is no more than 1 microcurie (µCi) and no dosimetry studies are required to support the radiolabeled dose selection. Learn more about the benefits of the Synthesis-to-Clinic program, which allows for a flexible approach to human ADME studies, and the breadth of supporting data and case studies that demonstrate both significant time and cost savings.