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Regulatory Focus™ > News Articles > SCIENCE & TECHNOLOGY: The Current Regulatory Landscape for Cardiac and Cardiovascular Safety Assess

SCIENCE & TECHNOLOGY: The Current Regulatory Landscape for Cardiac and Cardiovascular Safety Assessments—Part II

Posted 01 February 2011 | By Raymond A. Huml, MS, DVM, RACJ. Rick Turner

Last month, in Part I of this two-part series, we provided an overview of the history of formalized cardiac safety assessment, a brief discussion of the dedicated study used to investigate a drug's propensity to increase the length of the QT/QTc interval, and an overview of the regulatory history of formalized cardiovascular safety assessment for antidiabetic drugs for Type 2 Diabetes Mellitus (T2DM).

 

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