Frontage to Provide Full Service Human Radiolabeled Absorption, Metabolism, and Excretion Study Capabilities in Early 2021
Exton: Frontage Laboratories and Frontage Clinical Services are please to announce plans to provide full service human radiolabeled Absorption, Metabolism, and Excretion (hAME) study capabilities, subject to receipt of required regulatory approvals.
Building on over 20 years of experience in early phase clinical research study conduct, data management and biometric services, Frontage Clinical Services is expanding study conduct capabilities to include human AME studies. This service complements the existing key components of hAME studies, including Quantitative Whole-Body Autoradiography (QWBA)/dosimetry, mass balance, and metabolite identification/profiling studies which have been provided routinely by Frontage Laboratories for the last several years, resulting in a comprehensive hAME service offering.
Following fulfillment of federal and state radioactive material licensing requirements, Frontage plans to begin healthy volunteer recruitment and study conduct, including radiolabeled dosage preparation, at our 160-bed Phase 1 unit in Secaucus, New Jersey. We anticipate receiving regulatory clearance to begin studies in the first half of 2021.
“Having all required services for a human AME study available through the Frontage company is consistent with our stated strategy and ultimate goal to expand the range of Frontage services with more integrated solutions for our biotech and pharmaceutical clients”, said Dr. Song Li, CEO of Frontage Laboratories, Inc.
“Alignment of Frontage Labs DMPK strengths with Frontage Clinical Services expanded capabilities presents the opportunity to offer our clients end-to-end hAME services, ensuring efficient sample analysis and a seamless service experience “, said Dr. Lisa Diamond, President of Frontage Clinical Services, Inc.
About Frontage Laboratories, Inc.:
Frontage Labs is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. More details visit: www.frontagelab.com