The 2nd UMBC–Stanford Workshop
on Clinical Trials and Regulatory Science

Event Summary: A one-day workshop organized by the Center for Interdisciplinary Research and Consulting at the University of Maryland, Baltimore County (UMBC), and the Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.

Registration is now closed

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Organizing Committee:

Faculty from UMBC and Stanford University and leaders from FDA and industry.

For more information: Please contact Dr. Yi Huang, Department of Mathematics and Statistics, University of Maryland Baltimore County (UMBC), 1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.

For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.


Participant Information

Dalong Huang from FDA.

Paper: A simulation study to evaluate the performance of different models in concentration-QTc analysis

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. A simulation study was conducted to evaluate performance of different ER analyses using concentration QTc data and make recommendations on appropriate ER analyses.


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