Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
Systemic changes caused by exposure to test compounds are evaluated using data from in vivo general toxicity studies. But oftentimes, the conventional approach is not sufficient to elucidate the mechanisms of unexpected toxicity findings. Project teams must make agile and well-informed decisions for go or no-go; however, because there is only limited information about target- and structure-related biological responses especially in the discovery phase, it usually takes time to understand the mechanism of toxicity and identify a mitigation plan and screening strategies.
In our early safety strategy, we have proactively incorporated a compound profiling approach using liver tissue/cell samples as representative systems. Our primary objective is not only to understand the perturbed signals and pathways in liver and predict potential liver liabilities but also to gain insights into molecular mechanisms involved in toxicity observed in other tissues and organs. This approach has maximized the value of in vivo general toxicity studies and saved time of project teams to revise the safety strategy.
This presentation will introduce a case example of our approach and discuss how it can be implemented into the safety lead/candidate optimization and support the project decision-making in the discovery phase.
