QUALIFICATION PLAN FOR GLUTAMATE DEHYDROGENASE (GL

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QUALIFICATION PLAN FOR GLUTAMATE DEHYDROGENASE (GLDH) AS A BIOMARKER OF DRUG INDUCED LIVER INJURY IN INDIVIDUALS WITH SKELETAL MUSCLE DEGENERATION HISTORY

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Background Drug-induced liver injury (DILI) remains the single greatest cause for termination of development of drug candidates and withdrawal of approved drugs from the market (Yuan and Kaplowitz, 2013; Kaplowitz, 2005). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) serum activity measurements are used as current standard biomarkers for the identification of liver injury in clinical practice, and commonly used to assess risk of liver injury during drug developmen...

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QUALIFICATION PLAN FOR GLUTAMATE DEHYDROGENASE (GL • QUALIFICATION PLAN FOR GLUTAMATE DEHYDROGENASE (GL