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  • Print publication year: 2006
  • Online publication date: December 2009

Monitoring pharmaceutical interventions


This chapter discusses the use of vascular imaging data to advance the development of new therapies from the perspective of the pharmaceutical industry. It discusses the technologies currently used in large phase-3 studies, and addresses the technical, clinical, and regulatory considerations for the purpose of drug development and regulatory approval. M. A. Espeland reviewed the utility of carotid ultrasound as a clinical research tool to monitor atherosclerosis progression, and discussed the concept of surrogacy with respect to imaging data, and using the clinical and statistical criteria that are required for research data to be considered clinically meaningful. The chapter presents the angiography and intra- and extravascular ultrasound, to support their use in clinical trials for the development of antiatherosclerotic therapies. The technical validation elements to be addressed in a regulatory submission should have background information on the hardware, analytical software, training, data processing, data transfer, and quality control.