Cardiovascular Drug Development
Protocol Design and Methodology
1st Edition
Published on 1. November 1998
Book
Hardback
248 pages
978-0-8247-1927-2 (ISBN)
Description
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.
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.
More details
Series
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Professional and scholarly
Dimensions
Height: 279 mm
Width: 216 mm
Weight
590 gr
ISBN-13
978-0-8247-1927-2 (9780824719272)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Person
Content
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
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