ABSTRACT
Noninvasive imaging is a critical biotechnology tool for e¬cient pharmaceutical development. Precise measurement of pharmaceutical e›ects in vivo, in man, allows detailed study of target interaction and e›ects on pathology. Positron emission tomography (PET) enables measurement of uptake, distribution, and binding with high speciŸcity. Optimal application of the technology requires critical selection of spatial and temporal resolution to optimize the sensitivity for the speciŸc 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
13.1 Introduction .................................................................................... 13-1 13.2 Phases of Pharmaceutical Development ..................................... 13-2 13.3 State-of-the-Art Instrumentation for Clinical Trials ................13-3
13.5 Oncology Imaging .......................................................................... 13-7 Oncology Quantitation
13.7 Cardiac PET .....................................................................................13-9 13.8 Other ‘erapeutic Areas ............................................................. 13-10
13.10 Antibody Imaging ........................................................................ 13-11 13.11 Precompetative Consortia ........................................................... 13-12 13.12 Future Outlook .............................................................................. 13-12 References .................................................................................................. 13-13
to potential confounding e›ects minimized. Both scientiŸcally and from an operational and regulatory standpoint, PET imaging in pharmaceutical development has matured. Further research and work will be necessary to reŸne the technology, in order to reduce the number of study subjects required and increase the sensitivity to small changes.
