CARDIOVASCULAR DRUG DEVELOPMENT: PROTOCOL DESIGN AND METHODOLOGY. Questo articolo non è disponibile.CARDIOVASCULAR DRUG DEVELOPMENT: PROTOCOL DESIGN AND METHODOLOGY

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.

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