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FDA Guidance Highlights the Need to Evaluate Unique Human Metabolites
Plainsboro, NJ, March, 2008 – The recently released FDA guidance "Safety Testing of Drug Metabolites" (www.fda.gov/cder/guidance/6897fnl.pdf - 02-14-08) finalizes recommendations "on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are either identified only in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard nonclinical toxicology testing". This guidance encourages "the identification of differences in drug metabolism between animals used in nonclinical safety assessments and humans as early as possible during the drug development process".
With a long history providing services to identify, characterize and quantify metabolites from small molecules, XenoBiotic Laboratories, Inc. (XBL) stands ready to assist in the elucidation of unique and disproportionate human metabolites. XBL provides comprehensive clinical radiolabel study services, including metabolite radioprofiling and quantitation using state-of-the-art radiodetection methods. In addition, XBL provides a complete metabolism profiling package for drugs in early development through its core competency in metabolic pathway elucidation and metabolite identification of in vitro and in vivo samples across matrices and species, using the latest and most sensitive LC/MS/MS instrumentation for accurate mass determination and high-power NMR capability.
XBL strives to offer the latest advances in technology – advances that bring greater value to the core services it provides to the pharmaceutical, biotechnology, animal health and agrochemical industries. This recent FDA guidance reinforces XBL's leadership position in bioanalytical and metabolism services.
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