Cardiovascular Drug Development: Protocol Design and Methodology (Fundamental and Clinical Cardiology)
Books / Hardcover
Books › Medical › Cardiology
ISBN: 0824719271 / Publisher: Informa Healthcare, November 1998
Representing an annual series of symposia titled "Advances in Cardiovascular Pharmacology--Protocol Design and Methodology," contains material from the spring (US) and autumn (international) symposia of 1996 to 1997. Each drug development area is introduced with a brief overview discussion of the state of the field, highlighting areas of controversy as well as accepted approaches to amassing the database necessary for drug approval by regulatory agencies. Nineteen contributions are arranged in sections (each with a panel discussion included) on congestive heart failure, hypertension, arrhythmia, and lipid and ischemic therapy. Annotation c. by Book News, Inc., Portland, Or.
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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 Developmentexplores 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.
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