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Cardiovascular Drug Development: Protocol Design and Methodology (Fundamental and Clinical Cardiology)

✍ Scribed by John Somberg


Publisher
CRC
Year
1998
Tongue
English
Leaves
259
Edition
1
Category
Library

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✦ Synopsis


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 Β·explores the delicate balance of efficacy and safety that cardiovascular therapy must achieve to gain regulatory approval Β·discusses the search for surrogates and the need in some areas for natural history endpoints Β·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 Β·compares and contrasts the varying standards of evidence for drug approval in the United States, Europe, and Asia Β·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


Introduction......Page 10
Preface......Page 12
Contents......Page 16
Contributors......Page 18
Drug Discovery and Development......Page 20
Background Therapy in Congestive Heart Failure Studies......Page 68
Congestive Heart Failure Trial Design......Page 76
Angiotensin Converting Enzyme Inhibitors for Mortality Reduction in Congestive Heart Failure: Should Approval Be Granted for a Class Effect?......Page 82
Sudden Death in Congestive Heart Failure Trials......Page 90
Panel Discussion......Page 94
Antihypertensive Clinical Trials......Page 120
Calcium Channel Blockers: Safety Issues......Page 126
Panel Discussion......Page 140
Antiarrhythmics: Indications, Claims, and Trial Design......Page 158
Supraventricular Tachycardia Drugs and Trial Design Issues......Page 162
Antiarrhythmic Trials: Update......Page 166
Inter-Ethnic Differences in the Susceptibility to Drug-Induced QT Interval Prolongation and Torsade de Pointes......Page 172
Panel Discussion......Page 180
Antilipid Trial Endpoints......Page 200
Natural History Endpoints and Angina Trials......Page 208
Development of Antiplatelet Drugs......Page 212
Panel Discussion......Page 220
Future Directions of Cardiovascular Drug Development......Page 238
Index......Page 248


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