Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
In recent years, the term of “modality” has been used frequently in the pharmaceutical industry. It is considered that “modality” means drug discovery and therapeutic measures by innovative and new methods and mechanisms which are different from conventional ones. In the 20 century, small molecule drugs which chemically synthesized consist mostly of pharmaceutical products, and safety evaluation of these drugs was evaluable with corresponding guidelines for toxicity studies and testing methods, etc. Biological drugs such as antibodies and protein drugs have been gradually developed, making it difficult to handle conventional toxicity studies, and for this reason, new ways of thinking and evaluation have been discussed.
With the rapid progress of science and technology including IT, medical technologies (therapeutic methods) called “New Modalities” such as nucleic acid medicines, genetic therapies, and cell therapies are making rapid progress. However, the corresponding method of assessment is not appropriate. The goal of toxicologic pathology is to elucidate and analyze toxic changes due to exposure and/or treatment. Toxicologic pathology explores pathological conditions and the nature of diseases that occur in the living system. Elucidation of toxicity will eventually be verified by experimental pathology. Pathology, which evaluates morphological changes in the final assessment, is essentially unchanged even when the method changes. A key item of pathology is the final assessment of safety taking into account the benefit/risk of the medicinal product.
