Host: The Japanese Society of Toxicology
With the outbreak of SARS-CoV-2, there is a need for rapid IND and NDA for drugs against COVID-19. The development of the drugs needs to consider the administration to a wide range of COVID-19 patients in a short period of time and limited clinical trials. In addition, the weight of non-clinical safety studies is higher in the consideration of human safety compared to normal drug development, and it is necessary to be flexible in conducting studies. We will focus on the issues that PMDA considers particularly important in the development of therapeutic agents for COVID-19 from the viewpoint of non-clinical safety evaluation.
