8 December 2011

Join Vitalea Science at the Upcoming CACO Workshop in Foster City, CA on December 12

Vitalea Science is proud to be a major sponsor of this full day workshop focused on various aspects of performing radiolabelled human mass balance studies. These studies are required by regulatory authorities for registration of a new drug, and therefore, an integral part of the majority of drug development programs. Mass balance studies provide valuable information on rate and routes of elimination, mass balance, clearance mechanisms, metabolic profiles and relative abundance of metabolites in plasma and excreta but little guidance is available on how to perform and assess these complex studies. CACO organizers have assembled some of our industry's top scientists to address these issues and provide valuable guidance.

The FDA Guidance for Industry "Safety Testing of Drug Metabolites" (MIST - 90KB PDF) states that identification of the difference in drug metabolism between animals used in nonclinical safety assessments and humans should occur as early as possible during the drug development process. Vitalea's expertise and technology provides human ADME-based solutions to address the complexity of the current drug development landscape and meet regulatory expectations. Use of Accelerator Mass Spectrometry (AMS) to establish knowledge of human metabolites and physiochemistry in relation to safety species in early human studies avoids the impact of discovering MIST liabilities late in development. This enables critical decision making based on human safety and metabolism minimizing the risk of later stage failure.

We invite you to join us for this workshop and stop by the Vitalea booth to meet with our scientists. If you wish to arrange a meeting, please contact us directly at 801-706-2237, ahoffman@vitaleascience.com or visit the Vitalea website http://www.vitaleascience.com/. We look forward to seeing you in Foster City.

About Vitalea

Vitalea Science is a GLP compliant facility and is the first U.S.-based bioanalytical contract research organization dedicated to providing services for exploring the pharmacokinetics and metabolism of drug candidates directly in humans and non-clinical species using AMS, both prior to and as part of phase I clinical trials. In our Davis, CA facility, we utilize the BioMICADAS™, the only AMS instrument purpose-built to address the specific needs of the pharmaceutical industry. Vitalea is located in Northern California, about one hour from San Francisco and Napa Valley. We invite you to schedule a visit and view our GLP facility and discuss opportunities with our highly experienced staff of scientists.

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