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Article
The evolving role of investigative toxicology in the pharmaceutical industry
For decades, preclinical toxicology was essentially a descriptive discipline in which treatment-related effects were carefully reported and used as a basis to calculate safety margins for drug candidates. In r...
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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 ...
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Article
Open AccessA multicenter assessment of single-cell models aligned to standard measures of cell health for prediction of acute hepatotoxicity
Assessing the potential of a new drug to cause drug-induced liver injury (DILI) is a challenge for the pharmaceutical industry. We therefore determined whether cell models currently used in safety assessment (...
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Article
Open AccessEvidence-based selection of training compounds for use in the mechanism-based integrated prediction of drug-induced liver injury in man
The current test systems employed by pharmaceutical industry are poorly predictive for drug-induced liver injury (DILI). The ‘MIP-DILI’ project addresses this situation by the development of innovative preclin...
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Article
Challenges and approaches for the development of safer immunomodulatory biologics
Immunomodulatory biologics are a class of biotechnology-derived therapeutic products that are designed to engage immune-relevant targets and are indicated in t...
