Xceleron - Phase 1 enhancement

Xceleron works alongside leading pharmaceutical and biotechnology companies to meet the industry's most fundamental challenge: improving the efficiency and cost-effectiveness of drug development.

Xceleron uses 14C microtracers and ultra-sensitive accelerator mass spectrometry (AMS) in a powerful combination to provide unique early clinical insights into drug candidate performance in humans.

Pharmaceutical companies have exhibited great interest in the use of innovative phase 1 clinical study designs to quantify absolute bioavailability (and other fundamental kinetic parameters) and metabolite safety. Such studies have been designed by Xceleron in a way that adds a small increment to the existing expense of a human safety study.

Using a 14C microtracer combined with AMS allows absolute bioavailability information to be generated from a study design in which a sub-therapeutic intravenous dose is administered concomitantly with a therapeutic extravascular dose. This ideal clinical study design does not require IV toxicity data or extensive formulation of the IV dose. Metabolite safety has gained prominence since the publication of FDA and ICH guidelines in 2008 and 2009.

Xceleron has developed, in collaboration with its clients, a unique approach that provides a very cost-effective phase 1 metabolism screen. By pooling samples across subjects and time-points to form one sample for analysis, a human metabolite profile is produced that can be used to compare preclinical models.

Xceleron combines technical expertise with vast drug development experience and rigorous quality control procedures to provide its partners with data they can rely on. The company has developed the most extensive and validated quality infrastructure for the analysis of 14C by AMS.

Pharmaceutical and biotechnology customers have turned to Xceleron to help them make better-informed decisions throughout every stage of drug development. Xceleron-generated data has been used to support the marketing applications of seven approved drugs, and several others in late-stage testing.

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URL: www.xceleron.com

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