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Cardiac safety
This page provides general information on cardiac safety assessments in pre-clinical and clinical trials, including relevant publications and regulatory guidelines.
Cardiac Safety Advisory Board
This topic is managed by the Cardiac Safety Advisory Board:
Dr. Alex Dmitrienko (Lilly).
Dr. Georg Ferber (Novartis).
Dr. Scott Patterson (GlaxoSmithKline).
Dr. Arne Ring (Boehringer Ingelheim).
Dr. Brian Smith (Amgen).
Dr. Stan Young (National Institute of Statistical Sciences).
The Cardiac Safety Advisory Board encourages you to share your thoughts and information related to cardiac safety in this BioPhramNet discussion forum.
Regulatory guidelines
Pre-clinical guidance document
ICH S7B guidance document (S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals) was released in October 2005. Download the guidance document.
Clinical guidance document
ICH E14 guidance document (Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs) was released in October 2005. Download the guidance document.
Information on PhRMA QT statistics expert team chaired by Scott Patterson (GlaxoSmithKline) and Marylin Agin (Pfizer).
The Cardiac Safety Advisory Board is working on the development of an annotated bibliography of publications (papers, book chapters, etc) that deal with cardiac safety issues in pharmaceutical applications (with emphasis on cardiac repolarization and QTc prolongation).
A white paper written by Dr. Alex Dmitrienko, Dr. Charles Beasley and Dr. Malcolm Mitchell to facilitate an open discussion of issues related to the design and analysis of thorough QT studies.
Keep track of important cardiac safety events (conferences, workshops, training courses, webcasts, etc).