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Genotoxicity pharmacology

A full set of studies normally includes short-term and long-term animal studies on chronic effects and potential carcinogenicity, studies on reproductive and developmental toxicity, genotoxicity, kinetics and metabolism, pharmacological properties and special studies depending on the characteristics of the substance and observation in the standard set of studies. Human clinical studies may be necessary for substances which are metabolised and may interfere with functions of the human body. [Pg.233]

A rationale for determination, testing and control of genotoxic impurities. Regulatory Toxicology and Pharmacology, 44, 198-211. [Pg.268]

MPL Vaccine adjuvant Cardiovascular/respiratory function safety pharmacology study, repeat-dose toxicity in rat (up to 4wks—subcutaneous), rabbit and dog, reproduction (embryo-fetal studies in rat and rabbit) and 2 in vitro genotoxicity studies No adverse effects 40... [Pg.24]

Before human clinical trials are initiated, a number of toxicology studies need to be completed and documented in the IND submission. In addition to the studies listed above for toxicology developability assessment, preclinical toxicology studies include local tolerance, genotoxicity, safety pharmacology, and subchronic tests. [Pg.38]

See other pages where Genotoxicity pharmacology is mentioned: [Pg.130]    [Pg.7]    [Pg.62]    [Pg.116]    [Pg.439]    [Pg.517]    [Pg.635]    [Pg.223]    [Pg.119]    [Pg.234]    [Pg.249]    [Pg.261]    [Pg.266]    [Pg.268]    [Pg.325]    [Pg.325]    [Pg.327]    [Pg.15]    [Pg.1658]    [Pg.29]    [Pg.417]    [Pg.349]    [Pg.148]    [Pg.107]    [Pg.118]    [Pg.338]    [Pg.410]    [Pg.458]    [Pg.463]    [Pg.509]    [Pg.545]    [Pg.621]    [Pg.622]    [Pg.623]    [Pg.662]    [Pg.148]   
See also in sourсe #XX -- [ Pg.761 ]

See also in sourсe #XX -- [ Pg.761 ]



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GENOTOXIC

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