Designing a comprehensive cardiovascular safety testing regimen

There is no more vital organ in the body than the heart and any detrimental impact on its function is of a critical nature. Systemic exposure to drugs from a variety of therapeutic classes can have unanticipated and hazardous effects on the heart. In this white paper, Covance Inc. discusses the need for a careful analysis of any medicine's impact on cardiac safety. Recent scientific and regulatory initiatives are reviewed that propose a uniform and comprehensive range of testing in both the preclinical and clinical phases of development and testing.

In 2002, the Food and Drug Administration (FDA) and Health Canada (HC) jointly published a guidance document that proposed sweeping new recommendations for the clinical evaluations of QT/QTc interval prolongation and proarrhythmic potential including Phase 1 studies.

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