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.

Provides comprehensive exploration into the drug and biologic development process Benefits scientists across many fields in facilitating the understanding of pharmaco-imaging principles Explains how imaging tools can serve by providing high value data, images and kinetic information Includes supplementary material: sn.pub/extras

Autorentext
Mr. Brian R. Moyer is Owner/President of BRMoyer & Associates, LLC, Bedford, NH, consulting in medical imaging, radiation/chemical injury, and PK/TK services. He is under contract as a Sr. Science Advisor for HHS/BARDA, Washington, D.C., for Radiation-Chem countermeasure development. Mr. Moyer earned an M.S. in Pharmacology (Univ. of California, San Francisco), an M.S. in Toxicology (Univ. of San Francisco), and is board-certified in Nuclear Medicine Technology (CNMT). He has over 40 years in the imaging field with over 80 publications and has contributed toward six drug approvals. Dr. Narayan Cheruvu is Sr. Principal Clinical Pharmacologist at Covidien, St.Louis, MO. He earned a B.S. in Pharmacy (Andhra Univ.), an M.S. in Pharmacy (Institute of Technology-Banaras Hindu Univ., India) and a Ph.D. in Pharmaceutical Science (Nebraska Medical Center, Omaha, NE). Dr Cheruvu has more than 9 years in preclinical/clinical pharmacology, more than 20 publications and has contributed toward three drug approvals. Dr. Tom C.-C. Hu is a Project Officer at HHS/BARDA, Washington D.C., overseeing contracts for Radiation-Chem countermeasure development and rapid radiation biodosimetry. He is an Asst. Professor of Radiology (Medical College of Georgia) and served as Principal Scientist at GlaxoSmithKline PLC. Dr. Hu earned a B.S. in Chemistry (Univ. Pittsburgh), an M.S. and Ph.D. in Chemistry (Carnegie Mellon Univ), and an M.B.A (Villanova Univ).

Klappentext

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.

Inhalt

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.