2005

Cardiac Safety of Noncardiac Drugs

Practical Guidelines for Clinical Research and Drug Development

Editors:

ISBN: 978-1-58829-515-6 (Print) 978-1-59259-884-7 (Online)

Table of contents (18 chapters)

  1. Front Matter

    Pages i-xii

  2. Introduction

    1. Front Matter

      Pages 1-1

    2. No Access

      Book Chapter

      Pages 3-9

      Cardiac Safety of Noncardiac Drugs

  3. Preclinical and Pharmacogenomic Cardiac Safety Evaluations

    1. Front Matter

      Pages 11-11

    2. No Access

      Book Chapter

      Pages 13-36

      Molecular Physiology of Ion Channels That Control Cardiac Repolarization

    3. No Access

      Book Chapter

      Pages 37-66

      Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis

    4. No Access

      Book Chapter

      Pages 67-81

      hERG Assay, QT Liability, and Sudden Cardiac Death

    5. No Access

      Book Chapter

      Pages 83-103

      Pharmacogenomics in Drug Development

  4. Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization

    1. Front Matter

      Pages 105-105

    2. No Access

      Book Chapter

      Pages 107-129

      Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans

    3. No Access

      Book Chapter

      Pages 131-145

      ECG Acquisition and Signal Processing

    4. No Access

      Book Chapter

      Pages 147-166

      Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation

    5. No Access

      Book Chapter

      Pages 167-185

      Holter Monitoring for QT

  5. Application of ELectrocardiology in Clinical Research

    1. Front Matter

      Pages 187-187

    2. No Access

      Book Chapter

      Pages 189-203

      Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment

    3. No Access

      Book Chapter

      Pages 205-222

      Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs

    4. No Access

      Book Chapter

      Pages 223-227

      Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials

    5. No Access

      Book Chapter

      Pages 229-237

      Cardiac Arrhythmia Assessment in Phase IV Clinical Studies

    6. No Access

      Book Chapter

      Pages 239-257

      Statistical Analysis Plans for ECG Data

    7. No Access

      Book Chapter

      Pages 259-298

      Interpretation of Clinical ECG Data

  6. Regulatory COnsiderations

    1. Front Matter

      Pages 299-299

    2. No Access

      Book Chapter

      Pages 301-327

      The FDA’s Digital ECG Initiative and Its Impact on Clinical Trials

    3. No Access

      Book Chapter

      Pages 329-337

      Quality Control and Quality Assurance for Core ECG Laboratories

    4. No Access

      Book Chapter

      Pages 339-354

      ECG Digital Communities and Electronic Reporting of Cardiac Safety Data

  7. Back Matter

    Pages 355-361