Buch, Englisch, 362 Seiten, Previously published in hardcover, Format (B × H): 178 mm x 254 mm, Gewicht: 706 g
Practical Guidelines for Clinical Research and Drug Development
Buch, Englisch, 362 Seiten, Previously published in hardcover, Format (B × H): 178 mm x 254 mm, Gewicht: 706 g
ISBN: 978-1-61737-612-2
Verlag: Humana Press
It is generally easy to define the efficacy of a new the- peutic agent. However, what is even more difficult and more challenging yet more important is to define its safety when administered to millions of patients with multi-faceted d- eases, co-morbidities, sensitivities and concomitant medi- tions. The commonest cause of new drug discontinuations, cause for disapproval from marketing and removal from the market after approval is a drug’s effect on cardiac repolari- tion which is essentially identified by increasing the duration of the QTc interval duration on the standard 12-lead elect- cardiogram (ECG). Cardiac Safety of Noncardiac Drugs: Practical Guide- Joel Morganroth, MD lines for Clinical Research and Drug Development is designed to present the current preclinical, clinical, and re- latory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical gu- ance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by inter- tionally recognized experts with academic, industrial, and regulatory experience. Each chapter contains the best ava- able evidence, the author’s personal opinions, areas of c- troversy, and future trends. Although some of the areas are highly specialized, this book has been designed for a broad audience ranging from medical and graduate students to cli- cal nurses, clinical trial coordinators, safety officers, data managers, statisticians, regulatory authorities, clinicians, and Ihor Gussak, MD, PhD scientists.
Zielgruppe
Professional/practitioner
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin Kardiologie, Angiologie, Phlebologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
Weitere Infos & Material
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.
