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

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

ISBN-10:
0470229640
ISBN-13:
9780470229644
Pub. Date:
11/03/2008
Publisher:
Wiley
ISBN-10:
0470229640
ISBN-13:
9780470229644
Pub. Date:
11/03/2008
Publisher:
Wiley
Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance / Edition 1

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

Hardcover

$122.95
Current price is , Original price is $122.95. You
$122.95 
  • SHIP THIS ITEM
    In stock. Ships in 6-10 days.
  • PICK UP IN STORE

    Your local store may have stock of this item.


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.

Read an Excerpt

Click to read or download

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

From the B&N Reads Blog

Customer Reviews