Host: The Japanese Society of Toxicology
The relationship between QT interval prolongation and human proarrhythmic risk in non-clinical studies has been investigated in the drug development. After ICH-S7B guideline was issued, new in vitro test systems have been developed, and test results are being used as reference data for human risk assessment. In this presentation, we will discuss safety considerations in FIH for drugs with QT interval prolongation risk in non-clinical studies, and the reviewers' viewpoints on the human safety considerations in NDA. In addition, the reviewers' viewpoints on human risk assessment will be also reported when the results of new in vitro results are used in NDA, by using a case of a drug approved in Japan.
