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Drug-Metabolite Mediated Toxicity - Regulatory Perspective and practical approach

Presented by: Accelera Srl, Nerviano (Milan) - Italy

Short description: Drug metabolism might play a critical role in the safety profile of new candidates, revealing sometimes unexpected and unpredictable toxicological liabilities, or limiting the use of preclinical species.
Beside Regulatory Guidance aimed at addressing safety concerns, different tools and assays are now available to early identify the metabolic pathway in different experimental models, allowing to choose the most relevant species for toxicological studies and to predict possible adverse effects.
During this session practical approaches will be presented in addition to regulatory perspective, including case-study examples.



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