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Author: Shayne C. Gad
Publisher: CRC Press
Published: 2006-10-30
Total Pages: 950
ISBN-13: 142001420X
DOWNLOAD EBOOKReflecting more than a decade's worth of changes, Animal Models in Toxicology, Second Edition is a practical guide to the common statistical problems encountered in toxicology and the methodologies that are available to solve them. The book presents a historical review of the use of animal models and an overview of broad considerations of me
Author: National Research Council
Publisher: National Academies Press
Published: 2000-12-21
Total Pages: 348
ISBN-13: 0309070864
DOWNLOAD EBOOKScientific Frontiers in Developmental Toxicology and Risk Assessment reviews advances made during the last 10-15 years in fields such as developmental biology, molecular biology, and genetics. It describes a novel approach for how these advances might be used in combination with existing methodologies to further the understanding of mechanisms of developmental toxicity, to improve the assessment of chemicals for their ability to cause developmental toxicity, and to improve risk assessment for developmental defects. For example, based on the recent advances, even the smallest, simplest laboratory animals such as the fruit fly, roundworm, and zebrafish might be able to serve as developmental toxicological models for human biological systems. Use of such organisms might allow for rapid and inexpensive testing of large numbers of chemicals for their potential to cause developmental toxicity; presently, there are little or no developmental toxicity data available for the majority of natural and manufactured chemicals in use. This new approach to developmental toxicology and risk assessment will require simultaneous research on several fronts by experts from multiple scientific disciplines, including developmental toxicologists, developmental biologists, geneticists, epidemiologists, and biostatisticians.
Author: National Research Council
Publisher: National Academies Press
Published: 2004-06-04
Total Pages: 226
ISBN-13: 0309166411
DOWNLOAD EBOOKThe EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2013-04-25
Total Pages: 111
ISBN-13: 0309266335
DOWNLOAD EBOOKNervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.
Author: Asfar Azmi
Publisher: Academic Press
Published: 2019-04-17
Total Pages: 0
ISBN-13: 9780128147047
DOWNLOAD EBOOKAnimal Models in Cancer Drug Discovery brings forward the most cutting-edge developments in tumor model systems for translational cancer research. The reader can find under this one volume virtually all types of existing and emerging tumor models in use by the research community. This book provides a deeper insight on how these newer models could de-risk modern drug discovery. Areas covered include up to date information on latest organoid derived models and newer genetic models. Additionally, the book discusses humanized animal tumor models for cancer immunotherapy and how they leverage personalized therapies. The chapter on larger animal, canine models and their use in and their use in pre-investigational new drug (pre-IND) development makes the volume unique. Unlike before, the incorporation of several simplified protocols, breeding methodologies, handling and assessment procedures to study drug intervention makes this book a must read. Animal Models in Cancer Drug Discovery is a valuable resource for basic and translational cancer researchers, drug discovery researchers, contract research organizations, and knowledge seekers at all levels in the biomedical field.
Author: National Research Council
Publisher: National Academies Press
Published: 1990-02-01
Total Pages: 449
ISBN-13: 0309040477
DOWNLOAD EBOOKExposure to toxic chemicalsâ€"in the workplace and at homeâ€"is increasing every day. Human behavior can be affected by such exposure and can give important clues that a person or population is in danger. If we can understand the mechanisms of these changes, we can develop better ways of testing for toxic chemical exposure and, most important, better prevention programs. This volume explores the emerging field of neurobehavioral toxicology and the potential of behavior studies as a noninvasive and economical means for risk assessment and monitoring. Pioneers in this field explore its promise for detecting environmental toxins, protecting us from exposure, and treating those who are exposed.
Author: Andrea B Weir
Publisher: Springer Science & Business Media
Published: 2012-12-04
Total Pages: 327
ISBN-13: 1627031642
DOWNLOAD EBOOKOcular toxicity is routinely assessed in toxicology studies conducted for regulatory purposes. Ocular anatomy and physiology and the assessment of ocular toxicity itself can be challenging to scientists involved in the safety assessment of pharmaceuticals, pesticides and other agents. Anatomical and physiological differences between species can impact the nature of ocular effects observed following intended or unintended exposure of ocular tissues to xenobiotics. Ocular Toxicity in Laboratory Animals provides a concise reference addressing ocular anatomy and physiology across species that will enhance the design and interpretation of toxicology studies conducted for regulatory purposes. The book provides an overview of routine and advanced techniques that are used to assess ocular toxicity including slit lamp biomicroscopy, indirect ophthalmoscopy, electrophysiology and imaging methods for the anterior and posterior segments of the eye. Additionally, the book defines the regulatory expectations for pharmaceuticals intended to treat ocular diseases and for other non-pharmaceutical regulated chemicals. With contributions from experts in the field, Ocular Toxicity in Laboratory Animals is an authoritative, accessible guide for toxicologists and other scientists involved in conducting toxicology studies for regulatory purposes and/or reviewing data from such studies.
Author: National Research Council
Publisher: National Academies Press
Published: 2006-04-07
Total Pages: 270
ISBN-13: 0309164869
DOWNLOAD EBOOKToxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.
Author: National Research Council
Publisher: National Academies Press
Published: 2006-09-07
Total Pages: 87
ISBN-13: 0309102111
DOWNLOAD EBOOKThe National Institute of Allergy and Infectious Diseases (NIAID) gives the highest priority to developing countermeasures against bioterrorism agents that are highly infective when dispersed in aerosol form. Developing drugs to prevent or treat illnesses caused by bioterrorism agents requires testing their effectiveness in animals since human clinical trials would be unethical. At the request of NIAID, the National Academies conducted a study to examine how such testing could be improved. Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents provides recommendations to researchers on selecting the kinds of animal models, aerosol generators, and bioterrorism agent doses that would produce conditions that most closely mimic the disease process in humans. It also urges researchers to fully document experimental parameters in the literature so that studies can be reproduced and compared. The book recommends that all unclassified data on bioterrorism agent studies-including unclassified, unpublished data from U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)-be published in the open literature. The book also calls on the U.S. Food and Drug Administration to improve the process by which bioterrorism countermeasures are approved based on the results of animal studies.
Author: Hajime Kojima
Publisher: Springer
Published: 2018-12-27
Total Pages: 136
ISBN-13: 9811324476
DOWNLOAD EBOOKThis open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.
