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  1. No Access

    Article

    Managing the challenge of drug-induced liver injury: a roadmap for the development and deployment of preclinical predictive models

    Drug-induced liver injury (DILI) is a patient-specific, temporal, multifactorial pathophysiological process that cannot yet be recapitulated in a single in vitro model. Current preclinical testing regimes for ...

    Richard J. Weaver, Eric A. Blomme, Amy E. Chadwick… in Nature Reviews Drug Discovery (2020)

  2. No Access

    Article

    Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

    The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and anal...

    Frank Dieterle, Frank Sistare, Federico Goodsaid, Marisa Papaluca… in Nature Biotechnology (2010)

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    Protocol

    Use of Traditional End Points and Gene Dysregulation to Understand Mechanisms of Toxicity: Toxicogenomics in Mechanistic Toxicology

    Microarray technologies can be used to generate massive amounts of gene expression information as an initial step to decipher the molecular mechanisms of toxicologic changes. Identifying genes whose expression...

    Wayne R. Buck, Jeffrey F. Waring, Eric A. Blomme in Essential Concepts in Toxicogenomics (2008)