Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
The basic proposition of safety assessment in medicinal drug is "not to guarantee the safety of drugs, but to present the toxic effects, and to evaluate and manage risks in humans". In its implementation, it is necessary to understand that safety assessments (medicinal and toxic effects) are on the same platform of life-science based on multi-disciplinary sciences. In drug research and development, it is required to present an accurate information of the efficacy and toxicity, the mechanism of action, extrapolation to humans, risk evaluation (degree, tolerability, mitigation, avoidance), and risk management about appropriate application to patients.
In a practical manner, safety evaluation begins with understanding the pharmacological effects on disease-etiology, and follows by identifying the inducing toxicities. The basic concept of elucidating the toxicological action mechanism is to consider the two-sided thinking of MOA (mode of action) in efficacy and AOP (adverse outcome pathway) in toxicity. Presentation of toxicological action-mechanism leads to set the related biomarkers, and plays an important role in presenting the direction of risk management when applied to humans. In fact, it contributes for decision-making (Go or No-Go) at the timing of lead / candidate compound selection in the process of drug development. And also, it provides meaningful information for resolving the issue of clinical development.
In reality, it is undeniable that drug safety assessment would be developed based on regulatory scientific thinking from the aspect of approval application as a common practice. However, we must not forget that regulatory science is to be based on the foundation of life science, and that life science thinking is indispensable in future new medical field.
