Full Description
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.
Contents
Imaging Platforms and Drug Development: An Introduction.- Imaging in Drug Development: Animal Models, Handling and Physiological Constraints.- Considerations for Pre-Clinical Laboratory Animal Imaging Center Design, Setup, and Management suitable for Biomedical Investigation for Drug Discovery.- Pharmaco-Imaging in Translational Science and Research.- The Role of Pharmacokinetics and Allometrics in Imaging: Practical Issues and Considerations.- Quantitative Imaging Using Autoradiographic Techniques.- Pre-Clinical Imaging in Oncology: Considerations and Recommendations for the Imaging Scientist.- Use of Radiolabelled Leukocytes for Drug Evaluation in Man.- Application of Bioluminescence Imaging (BLI) to the Study of the Animal Models of Human Infectious Diseases.- Pre-Clinical Imaging in BSL-3 and BSL-4 Environments: Imaging Pathophysiology of Highly Pathogenic Infectious Diseases.- Magnetic Resonance as a Tool for Pharmaco-Imaging.- Technologies and Principles of Mass Spectral Imaging.- Regulatory Considerations Involved In Imaging.
