Toxicology, Safety Assessment, and Risk Management
Toxicology and safety assessment evaluate potential adverse effects of therapeutics on biological systems, ensuring risk mitigation before clinical application. Studies include acute, subchronic, and chronic toxicity, genotoxicity, reproductive toxicity, and immunotoxicity assessments. Preclinical and in vitro models, combined with computational toxicology, enhance predictive accuracy. Risk management strategies integrate pharmacovigilance, safety monitoring, and regulatory compliance. Advances in predictive modeling, high-content screening, and biomarker identification reduce late-stage failures and optimize drug safety profiles, supporting safe and effective therapy development.
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