EXTON, PA — Frontage Laboratories and Frontage Clinical Services this week announced they have developed the capability to perform full-service human Absorption, Metabolism, and Excretion (hAME) studies with radiolabeled compounds at their clinical site in Secaucus, NJ.
The Company states they have obtained the full approval of the NJ Department of Environmental Protection to conduct such studies evaluating radiolabeled drug candidates in humans. Frontage Clinical Services, which has over 20 years of experience conducting early phase clinical research studies, plans to begin healthy volunteer recruitment and study conduct in Q2 2021.
The ability to execute in-life hAME studies at their160-bed Phase 1 clinic in Secaucus, NJ complements Frontage’s extensive experience in conducting radiolabeled studies, including Quantitative Whole-Body Autoradiography (QWBA)/dosimetry, mass balance, and metabolite identification/profiling.
“Human radiolabeled studies are an essential component of successful NDA filing for new therapeutic agents. [This week’s] announcement is yet another example of Frontage’s ongoing expansion to become a global leader providing a full range of high-quality services under one roof,” said Dr. Song Li, CEO of Frontage Laboratories, Inc.
“The achievement of this important milestone is significant, as it allows us to offer our clients comprehensive hAME services, and enables us to provide an expanded portfolio of integrated solutions to the biotech and pharmaceutical industry,” said Dr. Lisa Diamond, President of Frontage Clinical Services, Inc.
“In the past, we have conducted mass balance and metabolite profiling studies for clients, but did not perform related in-life hAME services. We now have the ability to conduct entire hAME studies, including QWBA, right here in our facilities, allowing us to efficiently provide comprehensive hAME packages to clients in a very timely manner,” said Dr. Abdul Mutlib, Executive Vice President of Frontage Global DMPK Services.
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