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Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

The Mouse in Biomedical Research, Volume III: Normative Biology, Immunology, and Husbandry focuses on the normative biology, immunology, and husbandry of laboratory mice. Topics covered range from gnotobiotics and gastrointestinal microflora to animal health surveillance and health delivery systems, along with environmental monitoring. The management and design of breeding and research facilities are also discussed. Comprised of 18 chapters, this volume begins with an overview of studies involving gnotobiotic mice, the induction of gnotobiosis, and microbiological testing of gnotobiotic animals. Maintenance of breeding colonies of gnotobiotic animals is also considered, together with the shipment of gnotobiotes and laboratory facilities for using gnotobiotes. The reader is then introduced to management and design of breeding and research facilities for gnotobiotic mice; practical factors associated with providing adequate nutrition for laboratory mice; and environmental and equipment monitoring. Subsequent chapters deal with the basic biology of the mouse, including anatomy, embryology, reproductive physiology, physiology, endocrinology, hematology, clinical biochemistry, and gastrointestinal microflora. The book also examines immunoglobulins and immunoglobulin genes; lymphocyte immunogenetics; immune response disorders; and biomethodology and surgical techniques. This monograph will be useful to biologists, immunologists, researchers, and others those who use mice in the laboratory or are concerned with the production and maintenance of colonies of mice.

This book brings together a range of academic, industry and practitioner perspectives on translational medicine (TM). It enhances conceptual and practical understanding of the emergence and progress of the field and its potential impact on basic research, therapeutic development, and institutional infrastructure. In recognition of the various impli

Methods of Animal Experimentation, Volume I, provides information on the most common methods for using animals as tools in the search for new biological knowledge. The techniques described will facilitate the most efficient use of research animals and provide guidelines for their utmost comfort and welfare. The text is arranged according to specific research methods rather than to organ system or disease category. This approach gives the reader a broad view of the techniques involved in specific fields and describes the range of usefulness of these techniques. The first five chapters of the present volume describe basic information, methods, and principles involved in managing animals for experimental procedures. The remaining chapters deal with special techniques which have been demonstrated to be distinct, useful methods for using laboratory animals as a basic biomedical research tool. The descriptions of both fundamental and well-developed techniques of animal experimentation in various research fields should be useful to graduate students and experienced scientists who must consider variations in research approaches. The book is a source of information for the scientist administrator who is frequently confronted with different proposed approaches to biological research projects utilizing animals.

Methods of Animal Experimentation, Volume III, compiles methods of animal experimentation in a variety of fields so that the researcher might have a reference that would allow him to incorporate other techniques in his research studies. The methods described represent only the most efficient ways known to date for using animals to gain research information. They are not, however,''standard methods''for research in which each experiment seeks or confirms new information by another means. The largest portion of this volume is devoted to behavioral science because of the growing importance of this field in two respects. First, it is an important consideration in all experiments in which animals are used repeatedly. Second, the use of higher animals in comparative behavioral research offers much toward the solution of disease problems of man related to behavior and perhaps even clues to his social interactions. A chapter by an author with extensive experiences with dolphins helps us judge how this animal may be used, and warns of the many problems incurred in research using any of the marine mammals. Other chapters cover dental research on animals, fetal surgery and physiological measurements in very young animals, and microsurgery.

Methods of Animal Experimentation, Volume II, provides information on the most common methods for using animals as tools in the search for new biological knowledge. The techniques described will facilitate the most efficient use of research animals and provide guidelines for their utmost comfort and welfare. The text is arranged according to specific research methods rather than to organ system or disease category. This approach gives the reader a broad view of the techniques involved in specific fields and describes the range of usefulness of these techniques. The chapters in the present volume deal with special techniques which have been demonstrated to be distinct, useful methods for using laboratory animals as a basic biomedical research tool. The descriptions of both fundamental and well-developed techniques of animal experimentation in various research fields should be useful to graduate students and experienced scientists who must consider variations in research approaches. The book is a source of information for the scientist administrator who is frequently confronted with different proposed approaches to biological research projects utilizing animals.

Methods of Animal Experimentation, Volume V: Nutrition, Aging, and Artificial Organs is a collection of papers that deals with methods to be used in animal experiments to achieve cost effectiveness in their use. This collection discusses laboratory animals used in different experiments such as in nutritional research, aging studies, and artificial organ research. The papers describe the species of animals appropriate for the kind of experiment to be conducted and the criteria that should be followed in choosing a certain species. These criteria include their growth rate, stage of development, as well as existing performance variations. In determining test animals for aging experiments, the book recommends that complete data be available on the genetics of the species, strain, diet history, environmental factors, breeding, and spontaneous diseases to approximate the best test results. The book addresses that the aged are more susceptible to inputs than the young in terms of morphological and functional age. In selecting test animals for artificial organ research, the book notes the importance of animal selection that will be determined, for example, by 1) the size of the prosthesis; 2) the amount of blood flow needed for the device differs in animals and man; and 3) the surgical techniques that will be employed. This book will prove helpful for laboratory workers, veterinarians, and technicians working with laboratory animals. This collection will also be appreciated by researchers designing medical and scientific tests.

Methods of Animal Experimentation, Volume VII: Research Surgery and Care of the Research Animal, Part C is a collection of papers that deals with methods used in animal experiments concerning surgical approaches to certain organ systems such as the maxillofacial and skin systems. This collection deals with surgery involving the oral and maxillofacial, ophthalmic, skin systems, as well as research on canine immune systems and applications of microsurgery and laser surgery. One paper discusses orthognathic surgery including temporomandibular joint and dental implants. Another paper describes corneal procedures, lens extraction, and intraocular lenses. In discussing skin experimental surgery, the author explains procedures in flap anatomy, surgical healing, skin grafting, and burn treatment. The techniques in studying the immune systems of dogs include procedures dealing with peripheral blood, bone marrow, reactive cells, and tissues. Other authors explain the application of microsurgery to laboratory research including the equipment and techniques used, as well as the general principles of tissue transplantation into the animal's central nervous system. Another author discusses the use of lasers and special considerations such as laser restrictions and instrumentation. This book will be appreciated by laboratory assistants and scientists dealing with test animals, by veterinarians, and by researchers designing animal and medical experiments.

Methods of Animal Experimentation, Volume VII: Research Surgery and Care of the Research Animal, Part A is a collection of papers that deals with methods used in animal experiments involving patient care, vascular access, and telemetry. This book concerns technologies in experimental surgery — complicated procedures requiring longer observation time of the test animal, and an increase in the spectrum of animals that can be used. One paper describes the anesthesia, analgesia, and kinds of restraints that are suited for the test animal. A wide array of choices of inhalational agents, injectable, local anesthesia (lidocaine), analgesics (opioids and aspirin), and restraint (nonanesthesia and neuromuscular-blocking agents) is available for the researcher to choose from. Several authors also describe the use of telemetry devices that are implantable in test animals to achieve minimal interference from the investigator. These devices include sensors such as flow transducers and probes to use in pulse or continuous wave-applications; electromagnetic flowmeters for blood monitoring; and integrated circuits for various applications. One paper discusses postoperative care including a patient care checklist, treatment of common postoperative complications, as well as venous catheters for fluid administration. This text will be appreciated by veterinarians, technicians dealing with laboratory animals, and researchers designing animal and medical experiments.

Methods of Animal Experimentation, Volume IV focuses on research problems related to animal experimentation, including aging, nutrition, and environmental studies. It summarizes therapeutic implications of animal experimentation methods to human application. Chapter 1 presents an introduction to inhalation chambers including discussions of the types of inhalation tests, inhalation equipment and technology, methods of generation and measurement of contaminants, and some of the specialized techniques available for the pulmonary exposure of animals. Chapter 2 provides practical information about methods and the auditory abilities of animals. Chapter 3 outlines some basic properties of the vertebrate olfactory systems and summarizes selected experimental methods and findings in olfactory research. The concluding chapter describes the use of vertebrate laboratory animals in gustatory research, including some procedures unique to taste research. Research scientists, medical researchers, and olfaction and gustatory experts will find this book invaluable.

Methods of Animal Experimentation, Volume VI is a compendium of papers that defines which animals will prove most useful in biological experiments using the best methods in an environment of complex technologies and therapies. One paper reviews the genetic methods in animal experimentation including tests of Mendelian ratios, chromosomes crossing-over, chromosome anomalies, and gene transfer that produces congenic strains. Another paper explains the concepts and methodologies used in animals in ophthalmic research, particularly in ocular pharmacology, aqueous humor dynamics, glaucoma, and animal models of non-infectious uveitis. One paper analyzes the neural mechanisms of pain in an intact nervous system following ethical and moral principles of human treatment. For example, the use of different stimuli to elicit pain is applied only in situations where the stimuli is more appropriate, whether in behavioral or physiological experiments. The paper provides a list of requirements for the ideal pain stimulus. Another paper describes the methods in using standard animal models when an unknown agent is to be given as a general or local anesthesia. This book can prove beneficial to researchers, scientists, and laboratory technicians dealing with animals in relation to pharmacological, biological, chemical, and physiological research.