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Witryna13 lip 2024 · As N-nitrosamine impurities remain a potent “cohort of concern” according to ICH M7, risk assessments need to be performed as early as possible to ensure … WitrynaThis document provides guidance on the content and qualification of impurities in new drug products for registration applications. It applies to drug products produced from … WitrynaSafety Guidelines. ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent … shutterfly customer service 800