| 书目名称 | Cardiac Safety of Noncardiac Drugs | | 副标题 | Practical Guidelines | | 编辑 | Joel Morganroth (Chief Scientist, Clinical Profess | | 视频video | | | 概述 | Includes supplementary material: | | 图书封面 |  | | 描述 | Although it is relatively easy to determine the efficacy of a new drug, it is difficult to establish its safety when administered to millions of patients with multifaceted diseases, co-morbidities, sensitivities, and multiple drug use. In Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development, basic and clinical researchers from industry and academia detail the preclinical, clinical, and regulatory principles currently used to assess the cardiac safety of new drugs from their effects on the electrocardiogram (ECG). The authors explain the parameters of cardiac safety at all stages of clinical research and drug development, including both the preclinical and pharmacogenomic aspects generally and the clinical methodologies and technical aspects for investigational drugs based on cardiac repolarization, as defined by the duration of the QTc interval. Additional chapters comprehensively review the application of electrocardiology in clinical research, demonstrating the fundamentals of ECG interpretation in clinical trials, the statistical analysis plans for ECG data obtained in formal clinical trials, and the practical interpretation of the | | 出版日期 | Book 2005 | | 关键词 | clinical research; clinical trial; drug; drug development; electrocardiogram (ECG); electrocardiography; p | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-59259-884-7 | | isbn_softcover | 978-1-61737-612-2 | | isbn_ebook | 978-1-59259-884-7 | | copyright | Humana Press 2005 |
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发表于 2025-3-21 17:43:56
