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Study findings from National Center for Toxicological Research provide new insights into pharmaceuticals

Published in Medical Letter on the CDC and FDA, March 28th, 2010

Fresh data on pharmaceuticals are presented in the report 'Metabolomics approaches for discovering biomarkers of drug-induced hepatotoxicity and nephrotoxicity.' "Hepatotoxicity and nephrotoxicity are two major reasons that drugs are withdrawn post-market, and hence it is of major concern to both the FDA and pharmaceutical companies. The number of cases of serious adverse effects (SAEs) in marketed drugs has climbed faster than the number of total drug prescriptions issued," investigators in the United States report.

"In some cases, preclinical animal studies fail to identify the potential toxicity of a new chemical entity (NCE) under development. The current clinical...

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