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Genotoxic impurities stages

TABLE 10.1. Generic Staged TTC Values for Genotoxic Impurities During the Clinical Trial Stage for Pharmaceutical Candidate Compounds ... [Pg.258]

PhRMA published a draft position paper proposing a classification system for genotoxic impurities and associated limits during each phase of development based on the level of risk these impurities may pose on the safety of subjects participating in clinical trials. This staged TTC concept was also recommended for establishing limits for conunercial products. [Pg.17]

ANALYTICAL CONSIDERATIONS FOR GENOTOXIC AND OTHER IMPURITIES TABLE 1 Staged TTC Exposure Limits from the EMEA Guidance on Genotoxic impurities 173... [Pg.173]

See other pages where Genotoxic impurities stages is mentioned: [Pg.39]    [Pg.258]    [Pg.17]    [Pg.4]    [Pg.267]    [Pg.139]    [Pg.642]    [Pg.295]    [Pg.463]    [Pg.286]    [Pg.172]   
See also in sourсe #XX -- [ Pg.174 , Pg.175 , Pg.176 , Pg.177 ]



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