Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product <i>N</i>-Nitrosamine Impurities
Krista L. Dobo, Michelle Kenyon, Olivier Dirat, Maria Engel, Andrew J. Fleetwood, Matthew T. Martin, Susan Mattano, Alyssa Musso, J. Christopher McWilliams, Αλέξανδρος Παπανικολάου, Patricia Parris, Jessica Whritenour, Shu Yu, Amit S. Kalgutkar
Abstract
-dialkylnitrosamines, which translates to commensurately higher analytical method detection limits.
Topics & Concepts
CarcinogenChemistryNitrosamineImpurityDrugBiochemical engineeringOrganic chemistryPharmacologyMedicineEngineeringWater Treatment and DisinfectionSulfur Compounds in BiologyPolyamine Metabolism and Applications