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GEN News Highlights : Mar 19, 2013

Xceleron and JCL Bioassay Partner in Early Clinical Investigations

A new partnership between Xceleron and JCL Bioassay will offer drug developers access to a range of analytical platforms in early clinical development across Asia, Europe, and North America.

According to the companies, Phase 0 and enriched Phase 1 studies have been used successfully in recent years to investigate a range of developmental endpoints including drug presence at the tissue or cells of interest, absolute bioavailability, and human metabolism.

Between them, Xceleron and JCL Bioassay have developed over 100 analytical methods for Phase 0 and enriched Phase I investigations and both companies have recently built, equipped, and staffed laboratories specifically for the purpose of ultra-low level analyses under GLP and GCP conditions.

Xceleron provides bioanalytical AMS services for accelerated early drug development. The company works with human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials.

JCL Bioassay is a Japanese CRO and a global provider specialized in bioassay services in support of TK/PK studies for preclinical and clinical developments. The company provides expertise in bioanalytical method development, method validation/qualification, and study sample analysis for small and large molecules. The company also works with microdosing analysis in Japan.