Nonclinical Safety Evaluation for Virtual Drug Candidates -From the Standpoint of Regulatory Agency

Abstract

Regulators question the sponsor about any unknown matters in the consultation of the development of new drug and at the submission of new drug approval. However, there are cases in which regulator's thinking is not fully communicated because of differences in position and way of each thinking. In this presentation, we will outline our views on sponsor’s questions through the interpretations of (i) toxicities of virtual drug, (ii) a questionnaire survey and (iii) the accompanying guidelines. Through this presentation, we hope to help bridge the gap between sponsors and regulators.