Title Details

Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development,and Postmarketing Surveillance
Buy Rights Online Buy Rights

Rights Contact Login For More Details

  • Wiley

More About This Title Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development,and Postmarketing Surveillance

  • English

English

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.
  • English

English

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.
  • English

English

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.

  • English

English

“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

loading