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

ISBN-13: 9780470229644 / Angielski / Twarda / 2008 / 500 str.

J. Rick Turner; Todd A. Durham

Opis

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.

Recenzje

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)

Spis treści

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.

O autorze

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.

Blurb

A new, more effective approach for screening drugs for adverse cardiac effects

In recent years, more drugs have been withdrawn from the market for cardiac safety than for any other reason, underscoring the need for better methods and strategies to screen drugs for adverse cardiac effects. Integrated cardiac safety, this book′s central tenet, sets forth an effective strategy that enables researchers in drug discovery and development to better assess the cardiac safety of drugs. It entails the use and integration of the methodologies used to assess cardiac safety during the full life cycle of drug development from discovery and design through to postmarketing surveillance. Moreover, the integrated cardiac safety approach demonstrates the benefit of integrating proarrhythmic, generalized, and behavioral cardiac safety issues rather than treating them separately.

This book deals with drugs that are not indicated for cardiac diseases or conditions. It begins with an introduction to cardiac safety assessment and the biology of adverse drug interactions. Following sections on cardiac function and cardiac pathophysiology and disease, the authors guide readers through the assessment process during discovery, preapproval (including QT/QTc trials), and postmarketing surveillance. The book concludes with chapters on medication errors and an examination of future trends in drug safety.

"Turner and Durham′s book is well organized and comprehensive, providing both historical and prospective viewpoints. It provides practical information on drug safety throughout life cycle 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." â??Peter K. S. Siegl, PhD, 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 twenty–first–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." â??Peter J. Pitts, PhD, President, Center for Medicine in the Public Interest, and 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 increasinglyâ??and rightlyâ??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." â??Jay Campbell, JD, RPh, Executive Director, North Carolina Board of Pharmacy