Abstract
Japanese society of regulatory science, named “Society for Regulatory Science of Medical Products”, has been founded in 2010. Since then discussion has been made on this matter. Regulatory Science is necessary for nonclinical drug development as well as clinical and post marketing phases. We can see drug development as a series of decision making for Go/No go. Nonclinical studies provide data necessary for the decision making throughout all drug development phases. There are regulations like ICH guidelines for these nonclinical studies conducted before New Drug Application. Regulatory Science is necessary for preparation, harmonization and implementation of these guidelines. However, we usually need to conduct additional studies other than required ones in order to solve safety-related issues. Investigative nonclinical studies are essential when unexpected safety findings are found in regulatory required nonclinical studies and/or clinical trials to know mechanism(s) of these toxicities. Data derived from these investigative nonclinical studies are critical for the decision making. Thus Regulatory Science is essential to design and perform these studies. In this presentation, significance of Regulatory Science in nonclinical drug development will be discussed with some examples of our investigative studies.
