Titlebook: Genotoxicity and Carcinogenicity Testing of Pharmaceuticals; Michael J. Graziano,David Jacobson-Kram Book 2015 Springer International Publ

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Ritualforschung und Ritualtheorien,th effects especially related to impurities in drug substances or drug products. While ICH guidelines for “ordinary” impurities have been available for many years, a harmonized guideline on how to assess, limit and control potential health effects of low levels of genotoxic/carcinogenic impurities w

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Die Bedingungen für eine gute Regulirungue in predicting its carcinogenic potential. For new pharmaceuticals, test data from a standard test battery are required prior to administering the compound to humans. This test battery includes in vivo studies of chromosomal damage in the rodent hematopoietic system, traditionally performed in the

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