Cardiovascular Drug Development: (Fundamental and Clinical Cardiology)

These multidisciplinary presentations provide information essential to devising effective drug protocols in cardiovascular drug development, facilitating the approval process. Guides researchers and developers through the government drug approval process, facilitating development, minimizing costs, and harmonizing international standards employed in the creation of vital new cardiovascular therapies! Cardiovascular Drug Development explores the delicate balance of efficacy and safety that cardiovascular therapy must achieve to gain regulatory approval discusses the search for surrogates and the need in some areas for natural history endpoints reviews optimum strategies for protocol design in the development of drugs to treat hypertension, cardiac arrhythmias, heart failure, coronary artery disease, and hypercholesterolemia and other lipid disorders compares and contrasts the varying standards of evidence for drug approval in the United States, Europe, and Asia and more! Cardiovascular Drug Development will prove to be a valuable asset for cardiologists, pharmacologists and pharmacists, regulatory affairs specialists, and directors of research and development for pharmaceutical companies.

Table of Contents:
Drug Discovery and Development, John C. Somberg Development of Congestive Heart Failure Therapy Background Therapy in Congestive Heart Failure Studies, Jeffrey S. Borer Congestive Heart Failure Trial Design, Raymond John Lipicky Angiotensin-Converting Enzyme Inhibitors for Mortality Reduction in Congestive Heart Failure: Should Approval Be Granted for a Class Effect?, Jeffrey S. Borer and John C. Somberg Sudden Death in Congestive Heart Failure Trials, John C. Somberg Panel Discussion, Jeffrey S. Borer, Moderator Development of Antihypertensive Therapy Antihypertensive Clinical Trials, Raymond John Lipicky Calcium Channel Blockers: Safety Issues, Jeffrey S. Borer Panel Discussion, Jeffrey S. Borer, Moderator Development of Antiarrhythmic Drug Therapy Antiarrhythmics: Indications, Claims, and Trial Design, Raymond John Lipicky Supraventricular Tachycardia Drugs and Trial Design Issues, Robert Fenichel Antiarrhythmic Trials: Update, John C. Somberg Inter-Ethnic Differences in the Susceptibility to Drug-Induced QT Interval Prolongation and Torsade de Pointes, Satish Singh Panel Discussion, John C. Somberg, Moderator Development of Antilipid and Anti-Ischemic Therapy Antilipid Trial Endpoints, David Orloff Natural History Endpoints and Angina Trials, Raymond John Lipicky Development of Antiplatelet Drugs, Stephen Fredd Panel Discussion, Jeffrey S. Borer, Moderator Conclusion Future Directions of Cardiovascular Drug Development, Jeffrey S. Borer