Role of Imaging in Drug Development

摘要: Publisher Summary This chapter focuses on the emerging role of novel radiographic imaging in drug development process. The main purpose is to provide an overview how can facilitate development. Every step undertaken view regulatory requirements that will eventually need be satisfied for FDA approval. requires shows acceptable safety profile and adequate clinical benefit a defined patient population. shift toward less toxic, predominantly cytostatic agents renders traditional system inadequate. inadequacy seen throughout entire Limited resources are additional barrier current Use during diagnosis staging common familiar all clinicians. Depending tumor type location, anatomic using CT, MRI, or bone scintigraphy standard most cases delineating size extent malignancy. routine use these modalities more qualitative than quantitative due subjectivity interpretation among radiologists 2-18F-fluoro-2-deoxy-D-glucose (FDG)-PET universally available molecular technology approved by Centers Medicare Medicaid Services cancers non-small cell lung, breast, esophageal, colorectal, head neck, cervix, melanoma lymphoma, as well monitoring response treatment breast cancer. It has been invaluable tool planning other cancers.