Titlebook: Cardiac Safety of Noncardiac Drugs; Practical Guidelines Joel Morganroth (Chief Scientist, Clinical Profess Book 2005 Humana Press 2005 cli

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Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugschemical structures. Some examples include the antihistamine terfenadine; the antibiotic grepafloxacin; the antispasmodic terodiline; the calcium channel blocker lidoflazine; the atypical antipsychotic sertindole; the opioid levomethadyl; and the gastric prokinetic agent cisapride.

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Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials a drug’s potential to cause TdP. This chapter will focus on the use of standard 12-lead ECGs in phases II and III clinical development to assess a drug’s effect on cardiac intervals, durations, and morphologic patterns.

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Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesisivity in the form of early or delayed afterdepolarizations. Modulation of ion channel activity by drugs contributes to the development of both passive and active cardiac arrhythmias. The mechanisms responsible for active cardiac arrhythmias are generally divided into two major categories: (1) enhanc

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hERG Assay, QT Liability, and Sudden Cardiac Deathar) (.) have been associated with prolongation of the QT interval of the electrocardiogram (ECG), polymorphic ventricular tachycardia, torsades de pointes (TdP), and sudden cardiac death. Regulatory agencies such as the Food and Drug Administration (FDA) responded initially with severe labeling rest

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Assessment of Ventricular Repolarization From Body-Surface ECGs in Humanss called A, B, C, and D. Einthoven mathematically modified this signal to correct the inertia associated with the movement of the mercury column in the capillary electrometer. To avoid confusion with Waller’s recording, Einthoven named the five identified deflections P, Q, R, S, and T having used th