Cardiovascular Drug Development: Protocol Design And Methodology

Cardiovascular Drug Development: Protocol Design and Methodology

Pages: 248

Publisher: CRC Press

Year of Publication: 2016

Author(s) : John Somberg

Book 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.