Understanding the Implications of the 2014 IQ-CSRC Study on Assessing QT from Data Obtained in First–In-Human Studies
The definitive validation study results were announced at an FDA meeting in December 2014. The study creates a path for sponsors to successfully apply for waivers from stand-alone TQT studies and provides other benefits to sponsors. For complete information and White Paper download visit www.earlyprecisionqt.com.
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