Some Statistical Issues in Concentration-QTc Modeling
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Qianyu Dang, FDA/CDER  *Dalong Huang, FDA/CDER  Yi Tsong, US FDA CDER 

Keywords: ICH E14, Exposure Response

The ICH E14 clinical guidance was revised in December 2015. It now enables the use of exposure response (ER) analysis applied to early phase clinical data to provide definitive evidence of the lack of a QT effect of a drug in development. The highlight of the revised guidance will be provided. We will present statistical reviewers’ perspectives in concentration-QTc modeling based on FDA’s QT-interdisciplinary reviews and simulations.