A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the “Metabolites in Safety Testing” Regulatory Guidance

Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical...

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Veröffentlicht in:	Drug metabolism and disposition 2018-06, Vol.46 (6), p.865-878
Hauptverfasser:	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, Runge, Frank, Scheible, Holger, Spracklin, Douglas K., Swart, Piet, Tse, Susanna, Yuan, Josh, Obach, R. Scott
Format:	Artikel
Sprache:	eng
Schlagworte:	Drug development Drug metabolism Excretion Experimental methods Identification methods Mass spectrometry Mass spectroscopy Metabolism Metabolites Pharmaceutical industry Quantitation Safety
Online-Zugang:	Volltext
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