Synopsis
This work covers the ongoing revolution in immunology, biotechnology and the regulatory science of drug development. Topics include the molcular mechanisms of approved immunomodulators (tacrolimus, mycophenolate mofetil), induction of tolerance by donor-specific cell therapy and oral antigenic tolerization to genetically engineered cell translpants for diabetes and parkinsonism. The book also covers animal models, clinical pharmacology, practical issues in trial design and analysis, and the status of promising new agents to pharmo-economic principles of drug marketing. It offers a guide for taking new molecule or recombinant DNA peptide from concept, discovery, and preclinical research to clinical evaluation and post-marketing surveillance.
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