Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance / Edition 1

by J. Rick Turner, Todd A. Durham

Overview

The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. 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.

Product Details

ISBN-13:	9780470229644
Publisher:	Wiley
Publication date:	11/03/2008
Pages:	500
Product dimensions:	6.30(w) x 9.30(h) x 1.10(d)

About the Author

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.

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Table of Contents

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.

What People are Saying About This

From the Publisher

"Turner and Durham’s book is well-organized andcomprehensive, providing both historical and prospectiveviewpoints. It provides practical information on drug safetythroughout lifecycle development, from molecular biology topostmarketing surveillance. It will be an invaluable source ofinformation for those who want to learn about this area, as well asfor basic scientists, clinical investigators, physicians, andregulators currently wrestling with the diverse challenges ofcardiac safety."
—Peter K.S. Siegl, Ph.D., Siegl Pharma Consulting LLC

"At a moment in health care history when public policy and thepractice of medicine are on a collision course and meta-analysismadness threatens to derail 21st century drug development, Turnerand Durham strive to return us to the right path, the CriticalPath, brightly lit by practical advice and sound science. This is atimely and important book."
—Peter J. Pitts, PhD, President, Center for Medicine in thePublic Interest, Former Associate Commissioner, FDA

"Professors Turner and Durham provide a forward-looking guide tomedication safety issues relevant to all classes ofpharmaceuticals. And their guidance could not be more timely. Thepublic and policymakers are increasingly—andrightly—focused on safety issues at both the development andpostmarketing stages. The authors provide a synthesis of medicationsafety issues that is comprehensive, accessible, and that speaks toa wide range of health care professionals. Integrated CardiacSafety is an important, and welcome, work."
—Jay Campbell, JD, RPh, Executive Director, North CarolinaBoard of Pharmacy

Editorial Reviews

Reviewer: Surya M Artham, MD, MPH (Ochsner Clinic Foundation)
Description: This book nicely summarizes the importance of cardiac safety of drugs in the development process, pre-approval safety clinical trials, and post-approval surveillance.
Purpose: The prime objective of this book is to provide an overview of the steps involved in the approval of investigational agents, their associated cardiac safety issues, preclinical and clinical safety, and efficacy trials with these agents.
Audience: It is intended for pharmacists, clinical researchers, physicians, nurses, students, and allied healthcare professionals. It will be valuable to cardiovascular (CV) specialists and researchers interested in CV safety of cardiac and noncardiac therapeutic agents. The authors are well known and respected authorities in the field of clinical research in pharmacy.
Features: The book systematically highlights the steps involved in the approval of investigational agents for the market, specifically emphasizing the safety of these therapeutic agents on cardiac arrhythmias, generalized cardiac safety, and behavioral cardiac safety. The authors provide an in-depth review of the genetic pathways and other possible underlying mechanisms mediating adverse reactions of therapeutic agents. The book also covers the statistical methodologies applied in clinical trials, gives examples of some major CV drugs, and how and why they were taken off the market due to their adverse side effect profile. A noteworthy feature of this book is the way the authors cover the basics of all-important topics at the beginning of each chapter, making it easy to understand for newcomers in this field.
Assessment: 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 Review Service

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)

From the Publisher