Investigating Drug-Induced QT and QTc Prolongation in the Clinic: A Review of Statistical Design and Analysis Considerat
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Pbarmacrutical Research and Manufacturers of America 01 Stotistics Expert Working Team' Washington, District of Columbia Key Words QTc prolongation; Statistics; Design; Analysis; Interpretation Correspondence Address Scott D Patterson. Biomedical Data Sciences, GlaxoSmithKline Pharmaceuticals, 1250South Collegeville Road, Collegeville, PA 19426 (e-mail: [email protected]). The Drug Information Association is accredited by the Accreditation Councilfor Continuing Medical Education to provide continuing medical education for physicians. The Dtug Information Association designates this educational activityfor a maximum of 1 category 1 credit toward the AMA Physician's Recognition Award. Each physician should only claim those credits that he/ she actually spent in the activity.
Investigating Drug-Induced QT and QTc Prolongation in the Clinic: A Review of Statistical Design and Analysis Considerations: Report from the Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team The dangers inherent to the public via the use of drugs &own to prolong the QT and QTc in-
terval mch as terfenadine and cisapride call for a carefur evaluation of this potential in
drug developntent. Methods: in development
lustrated using data from clinical trials, and issues in the analysis and interpretation of data me dereioped. It is recommended that the statistical rigor of the lntemational Confmence on Hannonisation guidance currently assessment be enearch be conduddata.
The Drug Information As-
sociation is accredited by the Accreditation Council for Pharmacy Education as a provider of continuingpharmacy education. This program is designated for a maximum of 1 contact hour or. 1 continuing education units (CEUs). 286-000-05-412-HO4.
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bie to: the drug devdopment process Recognize ECG cdledionstandardsand i n t d measurements entfor pre-clinical and clinical assessment of drugs known to pdong
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Release Date: August 2005 Expiration Date: August 31,2006 Estimated time to complete the activity: 1 hour 'The Pharmaceutical Research and Manufacturers of America QT Statistics Expert Working Team is composed of: Scott Patterson, PhD (Chair), GlaxoSmithKline;Marilyn Agin, PhD (Chair) Pfizer; Rich Anziano, PhD. Pfizer; Tracy Burgess, Roche; Christy ChuangStein. PhD. Pfizer; Alex Dmitrienko. PhD. Eli-Lilly; Georg Ferber: PhD, Novartis; Margarida Geraldes, PhD. Bristol-Myers Squibb; Kalyan Ghosh, PhD, Merck; Ron Menton, PhD. Wyeth; Jaya Natarajan, PhD, Johnson 6 Johnson; Walt Offen. PhD, EliLilly; Jay Saoud, PhD. Aventis; Brian Smith. PhD Eli-Lilly; Ram Suresh. PhD, Schering Plough; and Nevine Zariffa, MMath, GlaxoSmithKline.
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INTRODUCTION Torsades de Pointes is a malignant ventricular arrhythmia known to occur infrequently in individuals who are genetically predisposed to this condition and sometimes in response to drug therapy (1). The potential for such an arrhythmia constitutes an important component of the riskhenefit assessment for medicinal products. Give
