Principles of Drug Development in Transplantation and Autoimmunity (Medical Intelligence Unit) - Hardcover

Lieberman, Ronald; Mukherjee, Asoke

 
9781570592836: Principles of Drug Development in Transplantation and Autoimmunity (Medical Intelligence Unit)

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Synopsis

This book is about an ongoing revolution in immunology, biotechnology and the emerging regulatory science of drug development. Its topics include the molecular mechanisms of recently approved immunomodulators (tacrolimus, mycophenolate mofetil), induction of tolerance by donor-specific cell therapy and oral antigenic tolerization to genetically engineered cell transplants for diabetes and parkinsonism. The book also covers animal models, clinical pharmacology, practical issues in trial design and analysis, current status of promising new agents to pharmaco-economic principles of drug marketing. It provides a guide for taking a new molecule or recombinant DNA peptide from concept, discovery and preclinical research to clinical evaluation and postmarketing surveillance.

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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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