Cardiovascular Safety in Drug Development and Therapeutic Use New Methodologies and Evolving Regulatory Landscapes /

• Main Authors: Turner, J. Rick (Author), Karnad, Dilip R. (Author), Kothari, Snehal (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Adis, 2017.
• Subjects: Medicine.; Cardiology.; Pharmacy.; Medicine & Public Health.; Drug Safety and Pharmacovigilance.

With the advent of multiple new therapeutic agents for a variety of important diseases has come an increasing realization that many of these drugs can have adverse effects on the heart and vascular system. As this book so elegantly details the mechanisms by which harm occurs are highly complex, many...

Table of Contents:

• The Central Importance of Cardiovascular Safety in Contemporary New Drug Development
• The Biological Basis of Drug Responses
• Cardiovascular Structure, Function, Pathophysiology, & Disease
• The Current Regulatory Landscape
• The "Comprehensive In Vitro Proarrhythmia Assay" Initiative
• The "Early ECG Assessment" Initiative
• The "Submission of Extended Digital ECG Data" Initiative
• Meta-analysis and Meta-methodology
• Current Regulatory Landscapes and their Potential Evolution
• Off-target Blood Pressure Responses to Non-cardiovascular Drugs
• Oncology Drug Development and Therapeutics: Cardiotoxicity Considerations
• Postmarketing Surveillance
• Regulatory Perspectives on General Drug Safety
• Future Directions in Cardiovascular Safety
• References.