Introduction to hepatic drug metabolizing enzyme induction in drug safety evaluation studies

Toxicologic Pathology
Suzanne BottsMichael Mohutsky

Abstract

The following three articles represent the output of a combined effort initiated by the Scientific Regulatory Policy Committee of the Society of Toxicologic Pathology to provide a unified review of current scientific practices and relevant literature and provide suggestions regarding the recognition, interpretation, and risk assessment of hepatic drug metabolizing enzyme (DME) induction studies. The core objective was to provide a review that the scientific community including pathologists, regulatory scientists, toxicologists, investigative scientists, and others would find valuable for managing, designing, and interpreting toxicity studies supporting regulatory filings. Three working groups composed of scientists from industry, academia, and regulatory agencies were convened to review the available literature on important aspects of the interpretation and risk assessment of hepatic microsomal DME enzyme induction in three publications. The three reviews are as follows: "Effects of Hepatic Drug Metabolizing Enzyme Induction on Clinical Pathology Parameters in Animals and Man," Toxicol Pathol "Hepatic Drug Metabolizing Enzyme Induction: Microscopic and Ultrastructural Appearance," Toxicol Pathol "Hepatic Drug Metabolizing Enzym...Continue Reading

References

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Nov 28, 2006·Expert Opinion on Drug Metabolism & Toxicology·Marcella MartignoniRuben de Kanter

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Citations

Apr 16, 2013·Toxicology Mechanisms and Methods·Amy C DitewigEric A G Blomme
Jan 13, 2015·Experimental and Toxicologic Pathology : Official Journal of the Gesellschaft Für Toxikologische Pathologie·Yuko ShimadaTakanori Harada
Mar 5, 2013·The Journal of Histochemistry and Cytochemistry : Official Journal of the Histochemistry Society·Rosario GarridoMudher Albassam
Jul 10, 2010·Toxicologic Pathology·Michael A MohutskySabine Francke-Carroll
Jun 30, 2010·Toxicologic Pathology·Robert R MaronpotJerrold M Ward
Jun 21, 2020·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Tingying JiaoHuichang Bi

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