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In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguard...
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research...
This updated and expanded Fifth Edition of Clinical Biochemistry of Domestic Animals brings together in a single comprehensive volume all the pertinent information regarding the biochemistry of disease and non-disease states in animals. Clinical veterinarians and animal scientists now routinely use many of the same diagnostic and therapeutic tools used to identify and treat diseases and metabolic disorders in humans, making this book an indispensable teaching, learning, and application resource for anyone engaged in the care, health, and welfare of animals. This book concentrates on the various rationales and interpretations regarding the biochemistry of disease in animals. It includes newly...
W. French Anderson, M.D. The publication of this book comes at an opportune time for the young field of human gene therapy. After a decade of long struggle at the laboratory bench and many long hours under the harsh lights of the federal review process, gene therapy has emerged as a legitimate scientific discipline. It is now time to move away from the period of questioning whether gene therapy will be a useful part of the physician armamentarium to begin to actively teach the concepts and practices that make gene therapy a reality. This book is a comprehensive collection of chapters that describe the basic biology and potential application of viruses as gene transfer reagents. It is not a coincidence that a modified virus was the reagent used in the first human gene therapy trials. Viruses have evolved with the human species (and most likely with all forms of life) to be the masters of gene transfer.
Cutting-edge collection of reviews and articles on HBV and HCV, as well as new emerging hepatitis viruses. Subjects include regulatory issues, epidemiology, emerging viruses, immunology, vaccines, pediatric HBV and HCV, genetics, pathology, viral diagnosis, cell systems, animal models, drug discovery and development, and prevention and treatment options for hepatocellular carcinoma. Book jacket.