Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control

The European Medicines Agency (EMA), the Pharmaceutical and Medical Devices Agency (PMDA), and the Food and Drug Administration (FDA) have issued guidelines for the conduct of drug-drug interaction studies. To examine the applicability of these regulatory recommendations specifically for induction,...

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Bibliographic Details
Published in:	Drug metabolism and disposition Vol. 45; no. 10; pp. 1049 - 1059
Main Authors:	Hariparsad, Niresh, Ramsden, Diane, Palamanda, Jairam, Dekeyser, Joshua G, Fahmi, Odette A, Kenny, Jane R, Einolf, Heidi, Mohutsky, Michael, Pardon, Magalie, Siu, Y Amy, Chen, Liangfu, Sinz, Michael, Jones, Barry, Walsky, Robert, Dallas, Shannon, Balani, Suresh K, Zhang, George, Buckley, David, Tweedie, Donald
Format:	Journal Article
Language:	English
Published:	United States American Society for Pharmacology and Experimental Therapeutics, Inc 01-10-2017
Subjects:	Consortia Cytochrome P-450 CYP2B6 - metabolism Cytochrome P-450 Enzyme System - metabolism Data interpretation Down-Regulation - physiology Drug Industry - methods Drug interaction Drug interactions Drug Interactions - physiology Drug metabolism Evaluation Guidelines Hepatocytes Humans Incubation Innovations Intelligence Leadership Medical devices Medical electronics Medical equipment Metabolism mRNA Pharmaceutical industry Pharmaceutical Preparations - metabolism Pharmaceuticals Regulatory agencies Scientists United States United States Food and Drug Administration Working groups
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