By Joel Morganroth, Ihor Gussak
Easy and medical researchers from and academia aspect the preclinical, scientific, and regulatory rules at the moment used to evaluate the cardiac safeguard of recent medications. The authors clarify the parameters of cardiac protection in any respect phases of scientific examine and drug improvement, together with either the preclinical and pharmacogenomic features more often than not and the scientific methodologies and technical features for investigational medications in line with cardiac repolarization, as outlined by means of the length of the QTc period. extra chapters comprehensively overview the applying of electrocardiography in scientific examine, the basics of ECG interpretation in scientific trials, the statistical research plans for ECG information acquired in formal scientific trials, and the sensible interpretation of the ECG effects. Highlights contain sensible counsel on tips to behavior an intensive ECG Trial in New Drug improvement, tips to use new ECG and net established know-how in scientific study, and the way to stick to the recent FDA necessities for ECG submissions.
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Additional info for Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development
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