Pharmaco-Imaging in Drug and Biologics Development: Fundamentals and Applications (AAPS Advances in the Pharmaceutical Sciences Series Book 8)

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. Front Matter....Pages i-xvii Imaging Platforms and Drug Development: An Introduction....Pages 1-43 Imaging in Drug Development: Animal Models, Handling and Physiological Constraints....Pages 45-62 Considerations for Preclinical Laboratory Animal Imaging Center Design, Setup, and Management Suitable for Biomedical Investigation for Drug Discovery....Pages 63-94 Pharmaco-Imaging in Translational Science and Research....Pages 95-112 The Role of Pharmacokinetics and Allometrics in Imaging: Practical Issues and Considerations....Pages 113-131 Quantitative Imaging Using Autoradiographic Techniques....Pages 133-185 Preclinical Imaging in Oncology: Considerations and Recommendations for the Imaging Scientist....Pages 187-213 Use of Radiolabelled Leukocytes for Drug Evaluation in Man....Pages 215-247 Application of Bioluminescence Imaging (BLI) to the Study of the Animal Models of Human Infectious Diseases....Pages 249-270 Preclinical Imaging in BSL-3 and BSL-4 Environments: Imaging Pathophysiology of Highly Pathogenic Infectious Diseases....Pages 271-290 Magnetic Resonance as a Tool for Pharmaco-Imaging....Pages 291-326 Technologies and Principles of Mass Spectral Imaging....Pages 327-353 Regulatory Considerations Involved in Imaging....Pages 355-390 Back Matter....Pages 391-401 Advances in drugs and biologics to mitigate or cure some of nature ́ s most complex medical problems have been incredible to behold.℗ These accomplishments are due to the actions of a wide theatre of participants from biologists, pharmacologists, geneticists, chemists and manufacturers, molecular biologists, toxicologists, clinicians, nurses, program managers, quality assurance personnel, regulatory professionals and ́ a new group of innovators ́ the Imaging Scientists.℗ Imaging has grown from the microscopy sections put on slides with special stains to now in vivo ́ slices ́ created with innovative physics, imaging tracers and contrast agents, and incredibly fast and accurate computational systems.℗ The world of biology has become one of witnessing the actions of drugs and biologics through the window of mechanical and electrical engineering ́ creating℗ instruments and reporter molecules that can help us ́ see ́ into our bodies and ́ paint ́ them with medical information needed to resolve disease. This book will inspire imagination and elicit even more innovations in the development of new and novel drugs and biologics through imaging