Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research.

This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.

Contents

Introduction

1. The Importance of Cardiac Safety Assessments
2. The Biological Basis of Adverse Drug Reactions

Cardiac Considerations

3. Cardiac Structure and Function
4. Cardiac Pathophysiology and Disease

Discovery and Nonclinical Development

5. Drug Discovery and Drug Design
6. Nonclinical Development

Preapproval Clinical Development

7. The "Thorough QT/QTc Trial"
8. General Safety Assessments

Postmarkeging Assessment Methodoligies

9. Therapeutic Use Trials and Meta-analyses
10. Assessment Methodologies in Nonexperimental Postmarketing Surveillance
11. Postmarketing Proarrhythmic Cardiac Safety Assessments
12. Generalized Cardiac Safety

Behavioral Cardiac Safety

13. Medication Errors, Adherence, and Concordance

Concluding Discussion

14. Future Directions in Drug Safety

Index

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