The volume aim to be a comprehensive overview of the drug and biologic development process that
is often called ¿the valley of death¿ (pre-IND through approval) where high costs of studies
and high rates of product failure are part of the drug development landscape. Imaging tools can
serve in this period by adding high value data the images and the kinetic information they can
provide and cost-effective development alternative tools which potentially improve pivotal
study designs. Imaging may identify safety issues early such as unwanted organ or tissue
distributions and then can serve advanced development with added certainty of a drug or
biologic¿s success to senior corporate management and investors. There are numerous textbooks
reference texts and treatises on medical imaging technologies teaching tools on medical cases
and physics books on the science of detector and computer interface systems. Rarely in each of
these are examples of medical imaging protocols and animal models of disease i.e. a text on
methodology in drug development is currently unavailable.
