Integrated Cardiac Safety (eBook)

J. Rick Turner, PhD, PGCE, MICR, is Chairman, Department of Clinical Research at Campbell University School of Pharmacy. Dr. Turner has extensive teaching, research, and pharmaceutical credentials and more than a dozen awards and honors, including a Commit to Product Development Award from GlaxoSmithKline. He is the author of seven books and more than 100 journal articles and published abstracts. Todd A. Durham, MS, is Senior Director of Biostatistics and Data Management at Inspire Pharmaceuticals. Prior to joining Inspire, Mr. Durham served as Associate Director of Biostatistics at Quintiles, Inc. Mr. Durham has made significant statistical contributions to six NDA submissions and has been involved with five presentations to FDA advisory committees.

Foreword.

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.

"This fills the void for a book addressing the safety issues, especially cardiac safety issues, of therapeutic agents in development. The content is high yield, easy to understand and succinct, covering the multiple steps involved in the drug safety and approval process." (Doody's, April 2009)

"Turner and Durham's book is well-organized and
comprehensive, providing both historical and prospective
viewpoints. It provides practical information on drug safety
throughout lifecycle development, from molecular biology to
postmarketing surveillance. It will be an invaluable source of
information for those who want to learn about this area, as well as
for basic scientists, clinical investigators, physicians, and
regulators currently wrestling with the diverse challenges of
cardiac 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