Synopsis
An authoritative presentation of the principles of pharmaceutical product development and regulatory science written by over 160 distinguished specialists and edited by the Medical Director of the US Public Health Service at the Food and Drug Administration and an FDA pharmacologist. The systematically organized volume discusses research areas involved in the molecular actions of immunodulators, the role of animal models in clinical pharmacology, issues in trial design and analysis, induction of tolerance by donor specific cell therapy, and cell transplants for diabetes and parkinsonism. Includes some photographs and illustrations. Annotation c. by Book News, Inc., Portland, Or.
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Synopsis
This book chronicles an ongoing revolution in immunology, biotechnology and the emerging regulatory science of drug development. Encompassing pharmaceutical drug and biologic development for transplantation and autoimmunity, this volume includes topics such as: the molecular mechanisms of recently approved immunomodulators (tacrolimus, mycophenolate mofetil); induction of tolerance by donor-specific cell therapy; oral antigenic tolerization to generically engineered cell transplants for diabetes and parkinsonism; animal models; clinical pharmacology; practical issues in trial design and analysis; and current status of promising new agents to pharmacoeconomic principles of drug marketing. This book is a guide for taking a new molecule or recombinant DNA peptide from concept, discovery and preclinical research to clinical evaluation and postmarking surveillance. The systematic approach delineated is relevant to the development of new agents for the treatment of disorders not involved with the immune system.
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Principles of Drug Development in Transplantation and Autoimmunity
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