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 The CNRU Mass Spectrometry Core Facility is your source for Metabolomics research.
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Drug Metabolism Research in Large Clinical Pharmacokinetic StudiesThe CNRU Mass Spectrometry Core Facility possesses the infrastructure and expertise to carry out pharmacokinetic and drug metabolism analyses for large clinical pharmacokinetic studies; the results from which are presented to the FDA. We also develop and validate LC-MS/MS assays to measure endogenous compounds for routine clinical monitoring and clinical trials. Pharmacokinetics and drug metabolism are keys to pre-clinical and clinical drug development.Our pharmacokinetic laboratory is fully 21 CFR part 58 compliant, accredited by College of American Pathologists, CLIA certified and has extensive expertise in FDA interactions and in writing reports for presentation to the FDA. Our expertise in drug metabolism includes evaluation of drug metabolism in vitro, structural identification of metabolites, production of drug metabolites using bacterial cultures, isolation of pure drug metabolites, identification of enzymes involved in drug metabolism, and enzyme kinetics. Our laboratory has also been on the forefront of studying active drug transport, especially p-glycoprotein in the small intestine and its interaction with intestinal drug metabolism. Our faculty has a more than 20-year track record in developing high-through put assays for clinical therapeutic drug monitoring using HPLC and HPLC/ mass spectrometry and has extensive experience in pharmacokinetic modeling. |
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