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  • Title: The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates.
    Author: Kramer JA, Sagartz JE, Morris DL.
    Journal: Nat Rev Drug Discov; 2007 Aug; 6(8):636-49. PubMed ID: 17643090.
    Abstract:
    Toxicity is a leading cause of attrition at all stages of the drug development process. The majority of safety-related attrition occurs preclinically, suggesting that approaches to identify 'predictable' preclinical safety liabilities earlier in the drug development process could lead to the design and/or selection of better drug candidates that have increased probabilities of becoming marketed drugs. In this Review, we discuss how the early application of preclinical safety assessment--both new molecular technologies as well as more established approaches such as standard repeat-dose rodent toxicology studies--can identify predictable safety issues earlier in the testing paradigm. The earlier identification of dose-limiting toxicities will provide chemists and toxicologists the opportunity to characterize the dose-limiting toxicities, determine structure-toxicity relationships and minimize or circumvent adverse safety liabilities.
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