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Toxicity analysis preclinical trials

The preclinical stage of drug development focuses on activities necessary for filing an IND/CTA. The completed IND/CTA contains information that details the drug s composition and the synthetic processes used for its production. The IND/CTA also contains animal toxicity data, protocols for early phase clinical trials, and an outline of specific details and plans for evaluation. Process research, formulation, metabolism, and toxicity are the major areas of responsibility in this development stage. Analysis activities that feature LC/MS primarily focus on the identification of impurities, de-gradants, and metabolites. [Pg.15]

See other pages where Toxicity analysis preclinical trials is mentioned: [Pg.237]    [Pg.29]    [Pg.1093]    [Pg.14]    [Pg.262]    [Pg.181]    [Pg.348]    [Pg.245]    [Pg.495]    [Pg.501]    [Pg.381]    [Pg.362]   
See also in sourсe #XX -- [ Pg.155 , Pg.156 ]



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