Are targeted contrast agents realistically going to reach the clinic? Recent regulatory experience with targeted MRI contrast agents.

摘要

Developments in the visualization of molecular events in vivo are progressing at an unprecedented rate, a characteristic of rapidly developing or emergent technologies. The need to target the molecular mechanisms of disease has been the driving force behind this rapid growth in knowledge whilst the bridging of disciplines, such as imaging science, chemistry and biology, in some cases with a good deal of entrepreneurship, has made such technological advances possible. At the vanguard is the field of targeted molecular imaging agents. Targeted molecular imaging agents are now used in biological, medical and pharmaceutical research where they are proving to be powerful tools in the investigation of experimental in vivo systems. It is almost taken for granted that these technologies will translate readily into clinical practice, providing unique molecular information on disease. But will targeted molecular contrast agents reach the clinic and deliver the benefits expected of them? Journals, conferences andsocieties are now dedicated to molecular imaging and targeted contrast agents. But to make an agent available to widespread clinical use requires regulatory approval from either the Food and Drug Administration (FDA) in the USA or the European Agency for the Evaluation of Medicinal Products (EMEA) in Europe. The main purpose of these agencies is to ensure that safe and efficacious agents reach the market while denying access to agents that do not meet these standards.