Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance

Preface.

Acknowledgments.

Abbreviations.

Part I: INTRODUCTION.

1. The Importance of Cardiac Safety Assessments.

2. The Biological Basis of Adverse Drug Reactions.

Part II: CARDIAC FUNCTION AND PATHOLOGY.

3. Cardiac Structure and Function.

4. Cardiac Pathophysiology and Disease.

SECTION III: DRUG DISCOVERY AND NONCLINICAL DEVELOPMENT.

5. Drug Discovery and Drug Design.

6. Nonclinical Development.

SECTION IV: PREAPPROVAL CLINICAL DEVELOPMENT.

7. The Thorough QT/QTc Trial.

8. General Safety Assessments.

SECTION V: POSTMARKETING ASSESSMENT METHODOLOGIES.

9. Therapeutic Use Trials and Meta-analyses.

10. Assessment Methodologies in Nonexperimental Postmarketing Surveillance.

11. Postmarketing Proarrythmic Cardiac Safety Assessments.

12. Generalized Cardiac Safety.

SECTION VI: BEHAVIORAL DRUG SAFETY.

13. Medication Errors, Adherence, and Concordance.

SECTION VII: INTEGRATIVE DISCUSSION.

14. Future Directions in Drug Safety.

References.

Index.