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Cardiac Safety of Noncardiac Drugs 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...
| Clasificación: | Libro Electrónico |
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| Autor Corporativo: | |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Totowa, NJ :
Humana Press : Imprint: Humana,
2005.
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| Edición: | 1st ed. 2005. |
| Temas: | |
| Acceso en línea: | Texto Completo |
Tabla de Contenidos:
- 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.