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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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