 Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance
ISBN: 978-0-470-22964-4
Hardcover
500 pages
November 2008
US $79.95
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Preface.
Acknowledgements.
SECTION I: INTRODUCTION.
1. The Importance of Cardiac Safety Assessments.
2. The Biological Basis of Adverse Drug Reactions.
SECTION II: CARDIAC CONSIDERATIONS.
3. Cardiac Structure and Function.
4. Cardiac Pathophysiology and Disease.
SECTION III: 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 Proarrhythmic Cardiac Safety Assessments.
12. Generalized Cardiac Safety.
SECTION VI: BEHAVIORAL CARDIAC SAFETY.
13. Medication Errors, Adherence, and Concordance.
SECTION VII: CONCLUDING DISCUSSION.
14. Future Directions in Drug Safety.
References.
Index.
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