ISBN 9780824719272,Cardiovascular Drug Development: Protocol Design and Methodology

Cardiovascular Drug Development: Protocol Design and Methodology


John Somberg


CRC Press

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CRC Press

Publication Year 1998

ISBN 9780824719272

ISBN-10 0824719271


Number of Pages 248 Pages
Language (English)


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.