Toronto, Canada (PRWEB) January 24, 2013
As requirements for cardiac studies tighten, the ICH-E14 guideline is essentially mandated for Thorough QT studies.
However, these studies are expensive and are usually performed late in Phase II or in Phase III, after many subjects have been exposed to an undefined repolarization risk. Also, by using the E-14 approach, a Sponsor will not learn of a drug’s QT liability until after a large expenditure of money and personnel effort.
A better assessment of QT liability can be achieved early in the drug development cycle, at lower cost to the Sponsor and lower risk to the subject. The strategy to achieve these goals will be discussed by the experts in this webinar.
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