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Journal Article Describes Methods to Assess Drugs’ Proarrhythmic Liability
Washington, DC – 01.June.2009 – Cardiocore, a premier centralized cardiac testing lab, announced that the Journal of Clinical Research Best Practices has published “Making Sense of Biostatistics: Assessing Drug Cardiac Safety,” authored by Cardiocore Senior Scientist, Professor Rick Turner, PhD, and Cardiocore Chief Medical Officer, Lawrence Satin, MD.
The article focuses on the clinical evaluation of investigational drugs’ potential to promote cardiac arrhythmia. Applying concepts established in the 2005 ICH Guideline E14 for evaluation of QT prolongation, the paper describes the basis to determine assay sensitivity, and methods to calculate subjects’ QT differences between placebo, therapeutic and supratherapeutic dosing.
Dr. Satin and Professor Turner are internationally recognized thought leaders in cardiac safety assessment for clinical trials. Their biographies along with information about their research and publications are available through Cardiocore’s corporate web site, www.cardiocore.com.
In May, the Journal of Clinical Research Best Practices distributed “Making Sense of Biostatistics: Assessing Drug Cardiac Safety” to its 90,000 subscribers, and reprints may be obtained by emailing info@cardiocore.com.
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| About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com |
