ABSTRACT
Noninvasive imaging is a critical biotechnology tool for ecient pharmaceutical development. Precise measurement of pharmaceutical eects in vivo, in man, allows detailed study of target interaction and eects on pathology. Positron emission tomography (PET) enables measurement of uptake, distribution, and binding with high specicity. Optimal application of the technology requires critical selection of spatial and temporal resolution to optimize the sensitivity for the specic clinical question. From knowledge of the pharmacokinetics of the PET tracer and the statistical properties of the measurement system, data analysis methods for each radiotracer and application have been developed. In this way, the measurement sensitivity to radioligands and targets has been maximized and the signal response
20.1 Introduction ....................................................................................20-1 20.2 Phases of Pharmaceutical Development .....................................20-2 20.3 State-of-the-Art Instrumentation for Clinical Trials ................20-3
20.7 Cardiac PET .....................................................................................20-9 20.8 Other erapeutic Areas .............................................................20-10
20.10 Antibody Imaging ........................................................................20-11 20.11 Precompetitive Consortia ............................................................20-12 20.12 Future Outlook ..............................................................................20-12 References ..................................................................................................20-13
to potential confounding eects minimized. Both scientically and from an operational and regulatory standpoint, PET imaging in pharmaceutical development has matured. Further research and work will be necessary to rene the technology, in order to reduce the number of study subjects required and increase the sensitivity to small changes.
