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Category Archives: Regulatory Affairs
FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies
Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS (ICH E14 (R3)) in 2005. … Continue reading
Posted in Cato Research, Drug Development, FDA, Regulatory Affairs, Uncategorized
Tagged Cato Research, drug development, FDA, guidance, regulatory affairs
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