http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Practical Guidelines for Clinical Research and Drug Development
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 results. Highlights include practical guidance on how to conduct a thorough ECG Trial in New Drug Development, how to use new ECG and web-based technology in clinical research, and how to follow the new FDA requirements for ECG submissions. Authoritative and up-to-date, Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development offers clinical researchers in industry and academia expert practical advice on establishing their product's cardiac safety, predicting regulatory actions, and getting it successfully to market.
Cardiac Safety of Noncardiac Drugs -- Preclinical and Pharmacogenomic Cardiac Safety Evaluations -- Molecular Physiology of Ion Channels That Control Cardiac Repolarization -- Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis -- hERG Assay, QT Liability, and Sudden Cardiac Death -- Pharmacogenomics in Drug Development -- Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization -- Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans -- ECG Acquisition and Signal Processing -- Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation -- Holter Monitoring for QT -- Application of ELectrocardiology in Clinical Research -- Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment -- Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs -- Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials -- Cardiac Arrhythmia Assessment in Phase IV Clinical Studies -- Statistical Analysis Plans for ECG Data -- Interpretation of Clinical ECG Data -- Regulatory COnsiderations -- The FDA’s Digital ECG Initiative and Its Impact on Clinical Trials -- Quality Control and Quality Assurance for Core ECG Laboratories -- ECG Digital Communities and Electronic Reporting of Cardiac Safety Data.