A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the “Metabolites in Safety Testing” Regulatory Guidance - Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K.; Funk, Christoph; Hop, Cornelis E.C.A.; Humphreys, W. Griffith; Igarashi, Fumihiko; James, Alexander D.; Kagan, Mark; Khojasteh, S. Cyrus; Nedderman, Angus N.R.; Prakash, Chandra; et al. (Drug metabolism and disposition, 2018)
Keywords: Animals; Drug development; Drug Discovery - standards; Drug Industry - standards; Drug Interactions - physiology; Drug metabolism; Excretion; Experimental methods; Humans; Identification methods; Inactivation, Metabolic - physiology; Mass spectrometry; Mass spectroscopy; Metabolism; Metabolites; Pharmaceutical industry; Pharmaceutical Preparations - metabolism; Quantitation; Safety; United States; United States Food and Drug Administration; FDA; ADME; AMS; DDI; MRM; AUC; ICH; HRMS; NMR; UPLC; NOAEL; MIST; ICRP; P450; HPLC