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

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Morganroth, Joel. (Editor ), Gussak, Ihor. (Editor )
Formato: eBook
Lenguaje:English
Publicado: Totowa, NJ : Humana Press : Imprint: Humana, 2005.
Edición:1st ed. 2005.
Materias:
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.