新闻

20 4 月, 2021

方达宣布在其位于新泽西州锡考克斯的临床中心使用放射性标记化合物进行全方位人体吸收、代谢和排泄 (hAME) 研究。

Exton PA: Frontage Laboratories and Frontage Clinical Services are pleased to announce that we have developed the capability to perform full-service human Absorption, Metabolism, and Excretion (hAME) studies with radiolabeled compounds at our clinical site in Secaucus, NJ.  We 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 our 160-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.  Today’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.

 

Visit our website to learn more about our DMPK  和来自 Provantis® 数据采集系统的 临床服务.

 

 

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.