Insightful Corporation Announces Webinar on “Graphical Evaluation for Cardiovascular Safety Data in Clinical Trials”
Principal Scientist in the Advanced Modeling and Simulation group at Johnson & Johnson Pharmaceutical Research & Development to Present
Seattle - July 16, 2008 -
Insightful Corporation (NASDAQ: IFUL), a leading provider of predictive analytics and reporting solutions, announced today the company will host a free webinar titled “Graphical Evaluation for Cardiovascular Safety Data in Clinical Trials” on July 17, 2008 from 8:30 to 9:30 am, Pacific Daylight Time. Dr. Ihab G. Girgis, a principal scientist in the Advanced Modeling and Simulation group at Johnson & Johnson Pharmaceutical Research & Development, will lead the webinar.
During the webinar, Dr. Girgis will explore the graphical evaluation of baseline QT clinical data and its modeling. Detecting the drug-induced effect on cardiac repolarization or QT interval is a closely monitored safety element in drug development and more recently, it has also been scrutinized in regulatory submissions. Length of the QT intervals can be influenced by a number of covariates, such as heart rate (HR), RR interval (RR= 60/HR), gender, and natural circadian rhythm.
There are other unknown factors that influence this interval, making it highly variable across populations. As such, the analysis of these data is complex. In order to evaluate the effect of drug on QT interval, accurate modeling of drug-free baseline QT becomes an important first step. Subsequent changes to this baseline model after the administration of an investigational drug can reflect the effect of the investigational drug on the QT/QTc interval.
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