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Toxicology formulation

Gad and Cassidy (2006) summarized the comprehensive information of maximum tolerabilities for 65 single component vehicles used in 368 studies across multiple species (e.g., dog, primate, rat, mouse, rabbit, guinea pig, minipig, chick embryo, and cat) by multiple routes. The paper serves as a good reference for excipient selection in the toxicology formulation development. [Pg.127]

Analytical methods for assay of the toxicology formulations and cleaning validation are developed and validated in preparation for the first GLP studies. Release and stability testing of the toxicology test articles are performed to support the suitability of the materials through their anticipated period of use. Typically, short-term accelerated stability studies are performed on the toxicology batches for at least 3 months to cover the time from date of manufacture through the last dose. [Pg.504]

New and revised internal methods (for cleaning validation release and stability testing of drug substance and toxicology formulations)... [Pg.505]

Ongoing stability of toxicology test articles or stability studies of new toxicology formulations... [Pg.505]

See other pages where Toxicology formulation is mentioned: [Pg.226]    [Pg.5]    [Pg.127]    [Pg.429]    [Pg.138]    [Pg.142]    [Pg.503]    [Pg.504]    [Pg.29]    [Pg.408]    [Pg.409]    [Pg.422]    [Pg.187]    [Pg.3617]    [Pg.345]    [Pg.121]    [Pg.121]    [Pg.531]    [Pg.531]    [Pg.532]    [Pg.533]    [Pg.40]    [Pg.218]   


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