Cardiac Safety of Noncardiac Drugs Practical Guidelines for Clinical Research and Drug Development /

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Morganroth, Joel (Επιμελητής έκδοσης), Gussak, Ihor (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Totowa, NJ : Humana Press, 2005.
• Θέματα: Medicine.; Pharmacology.; Biomedicine.; Pharmacology/Toxicology.

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...

Πίνακας περιεχομένων:

• 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.