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hepatology metabonomics metabolomics

Mark I Avigan, Einar S Bjornsson, Markku Pasanen, Charles Cooper, Raul J Andrade, Paul B Watkins, James H Lewis, Michael Merz
A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential...
November 2014: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Neeral R Patel, Mark J W McPhail, Mohamed I F Shariff, Hector C Keun, Simon D Taylor-Robinson
Metabolic profiling or 'metabonomics' is an investigatory method that allows metabolic changes associated with the presence of an underlying pathological process to be investigated. Various biofluids can be utilized in the process but urine, serum and fecal extract are most pertinent to the investigation of gastrointestinal and hepatological disease. Nuclear magnetic resonance spectroscopy-based metabonomic research has the potential to generate novel noninvasive diagnostic tests, based on biomarkers of disease, which are simple and cost effective yet retain high sensitivity and specificity characteristics...
April 2012: Expert Review of Gastroenterology & Hepatology
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