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Carcinogenicity studies biopharmaceuticals

Carcinogenicity Studies When the following points are confirmed, generally, carcinogenicity studies are not necessary even when a biopharmaceutical is used for a long period ... [Pg.105]

Carcinogenicity study in mice and rats These studies are designed to identify a tumorigenic potential and to assess the relevant risk in humans. These studies are conducted for pharmaceuticals that are generally administered over the life of a human and are generally not conducted for biopharmaceuticals (see Chapters 19 and 27). [Pg.853]

Drug Studies in Pediatric Patients Medical Officer s Review Statistical Review Evaluation Chemistry, Manufacturing and Controls CDER Labeling and Nomenclature Committee Clinical Pharmacology/Biopharmaceutics Microbiologist s Review Pharmacokinetics Review Carcinogenicity Assessment... [Pg.781]

May be only feasible approach if no usable species responding to the clinical biopharmaceutical is available (e.g., no terminable studies feasible in chimpanzees, carcinogenicity testing not feasible in NHPs)... [Pg.57]

See other pages where Carcinogenicity studies biopharmaceuticals is mentioned: [Pg.85]    [Pg.96]    [Pg.97]    [Pg.97]    [Pg.106]    [Pg.108]    [Pg.120]    [Pg.278]    [Pg.344]    [Pg.509]    [Pg.869]    [Pg.963]    [Pg.965]    [Pg.12]    [Pg.364]    [Pg.61]    [Pg.106]    [Pg.337]    [Pg.404]    [Pg.406]    [Pg.412]    [Pg.427]    [Pg.512]    [Pg.513]    [Pg.583]    [Pg.204]    [Pg.313]   
See also in sourсe #XX -- [ Pg.965 ]



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