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- W997728364 abstract "AbstractSince 1996, worldwide regulatory authorities have been providing guidance on cardiac safety as assessed by the standard 12-lead electrocardiogram (ECG), with the European Union’s Committee for Proprietary Medicinal Products (CPMP) document (“Points to Consider”) for the evaluation of the potential for QT prolongation with noncardiovascular medicinal products in both preclinical and clinical studies. The initiative gained momentum with Health Canada’s March 2001 draft guidance document entitled “Assessment of the QT Prolongation Potential of Non-Antiarrhythmic Drugs,” and continued to evolve with the November 2002 joint FDA-Health Canada concept paper entitled, “The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs” (see http://www.fda.gov/cder/guidance/index.htm for details). Since 2002, an accelerating focus on cardiac safety in new drug development has been observed throughout the international clinical research industry. Throughout 2003 and 2004, cardiac safety guidance advanced from discussions held as part of the International Conference on Harmonization process, with strong input from research industry and regulatory authorities in Europe and Japan.KeywordsCardiac SafetyElectronic ReportingRhythm StripDigital CommunityClinical Trial ProcessThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves." @default.
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- W997728364 date "2007-10-09" @default.
- W997728364 modified "2023-09-25" @default.
- W997728364 title "ECG Digital Communities and Electronic Reporting of Cardiac Safety Data" @default.
- W997728364 doi "https://doi.org/10.1007/978-1-59259-884-7_18" @default.
- W997728364 hasPublicationYear "2007" @default.
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