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Friday, April 20, 2018

The Role of Metabolism in Personalized Medicine

Plainsboro, NJ, December 22, 2005 - There are many examples of drugs that show altered efficacy or safety profiles in extensive metabolizing (EM) or poor metabolizing (PM) subpopulations. EM and PM subpopulations have been linked to the functionality of specific cytochrome p450 enzymes that are responsible for a drug's metabolism. Indeed, genotyping individuals for mutations in drug metabolism enzymes (DMEs) to predict patient outcome is becoming increasingly important in drug development. One striking example was presented recently at the ACCP annual meeting in Rockville MD, Sept 11-13, 2005 in a symposium entitled "Emerging Pharmacogenomic Tools & Their Utility in Benefit/Risk Assessment During Drug Development & in Clinical Trials" chaired by Shiew-Mei Huang, Ph.D, Deputy Director for Science, Office of Clinical Pharmacology & Biopharmaceutics, CDER, FDA. David Flockhart M.D.,Ph.D., of Indiana University School of Medicine presented data to suggest that the chemotherapeutic Tamoxifen is more efficacious in patients with fully functioning CYP2D6 due to the potency of two major metabolites, Endoxifen and 4-OH-Tamoxifen, and that a CYP2D6 variant genotype reduced disease free survival in a randomized, prospective trial.

As the pharmaceutical industry looks to develop drugs with efficacy in specific subpopulations based on a genetic predisposition for metabolism, a complete understanding of the metabolism profile in humans becomes paramount.

At XenoBiotic Laboratories, Inc. (XBL) we have extensive expertise in quantifying subtle or major differences in the metabolism profile of small molecules in EM and PM subjects. XBL provides a complete metabolism profiling package for drugs in early development through its core competencies in metabolite radioprofiling and quantitation using state-of-the-art radiodetection methods and metabolic pathway elucidation and metabolite identification using the latest and most sensitive LC/MS/MS instrumentation for accurate mass determination.

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. For additional information on Pharmacogenomics in drug development please refer to www.fda.gov/cder/genomics/.