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Toxicology Studies

 Toxicology studies are used to characterize the toxicity profile of a drug by identifying its impact on organ structure and / or functionality. This includes assessment of the severity and reversibility of toxicity, as well as dose ranges and their relationship to exposure. Ultimately, these toxicology studies aid in determining if, and to what degree, the biologic’s toxicity is dose-dependent, species-specific, mechanism-related and / or related to the method of administration. By understanding the injuries that could occur to kidneys, the heart, muscles, and other vital organs, toxicology studies help to determine the margin of safety of a drug for its expected clinical dose. 

 

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