Integrated cardiac safety: assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance

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-friendlytext is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students. INDICE: Foreword: Professor David Triggle, SUNY at Buffalo. Preface. Acknowledgements. SECTION I: INTRODUCTION. 1. The Importance of Cardiac Safety Assessments. 2. The Biological Basis of Adverse Drug Reactions. SECTION II: CARDIAC CONSIDERATIONS. 3. Cardiac Structure and Function. 4. Cardiac Pathophysiology and Disease. SECTION III: 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 Proarrhythmic Cardiac Safety Assessments. 12. Generalized Cardiac Safety. SECTION VI: BEHAVIORAL CARDIAC SAFETY. 13. Medication Errors, Adherence, and Concordance. SECTION VII: CONCLUDING DISCUSSION. 14. Future Directions in Drug Safety. References. Index.

• ISBN: 978-0-470-22964-4
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 500
• Fecha Publicación: 14/11/2008
• Nº Volúmenes: 1
• Idioma: Inglés