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FDA Draft Guidance Highlights the Need to Evaluate Unique Human Metabolites
Plainsboro, NJ, September 1, 2005 - The recent FDA draft guidance "Safety Testing of Drug Metabolites" (June 2005: www.fda.gov/cder/guidance/index.htm) makes recommendations on when and how to identify, characterize and evaluate the safety of unique and major metabolites of small molecule drug products. This guidance suggests that such metabolites may not be adequately assessed during standard nonclinical studies because they occur only in humans (unique metabolite), or at much higher levels (major metabolite) in humans than in the species used during standard nonclinical toxicology testing. The guidance recommends that in vitro and in vivo metabolic evaluation of human samples be performed as early as feasible to identify potential unique and major human metabolites that may need pharmacological/toxicological evaluation in preclinical species.
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 major 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 This recent draft guidance reinforces XBL's leadership position in bioanalytical and metabolism services.
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