Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance
PartA I: INTRODUCTION.
1. The Importance of Cardiac Safety Assessments.
2. The Biological Basis of Adverse Drug Reactions.
PartA 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.
—Peter K.S. Siegl, Ph.D., Siegl Pharma Consulting LLC
"At a moment in health care history when public policy and the practice of medicine are on a collision course and meta-analysis madness threatens to derail 21st century drug development, Turner and Durham strive to return us to the right path, the Critical Path, brightly lit by practical advice and sound science. This is a timely and important book."
—Peter J. Pitts, PhD, President, Center for Medicine in the Public Interest, Former Associate Commissioner, FDA
"Professors Turner and Durham provide a forward-looking guide to medication safety issues relevant to all classes of pharmaceuticals. And their guidance could not be more timely. The public and policymakers are increasingly—and rightly—focused on safety issues at both the development and postmarketing stages. The authors provide a synthesis of medication safety issues that is comprehensive, accessible, and that speaks to a wide range of health care professionals. Integrated Cardiac Safety is an important, and welcome, work."
—Jay Campbell, JD, RPh, Executive Director, North Carolina Board of Pharmacy