PAPER: USE OF CONCENTRATION-EFFECT MODELLING FOR CARDIAC SAFETY ECG ASSESSMENTS

It's been one year since new regulatory guidance allowed sponsors to potentially use Phase I SAD/MAD data to assess the cardiac safety of new drugs instead of a Thorough QT (TQT) trial. As the industry leader in cardiac safety and a QTc expert in early phase development, ERT delivers specialized solutions and complete flexibility to ensure safety so you can move ahead quickly. Read a paper by ERT's Chief Medical Officer, Dr. Robert Kleiman, recently published in the Journal for Clinical Studies on the science and options to successfully accomplish Phase I QTc assessment.

 

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