Principles of Animal Extrapolation addresses the conceptual basis for animal extrapolation and provides an abundance of documentation that illustrates how these principles may be applied in the selection of the more appropriate models and in the interpretation of toxicological studies. The book analyzes and documents each specific biological cause of interspecies differences in susceptibility to toxic agents, including differences in absorption, gut flora, tissue distribution, metabolism, mechanisms and efficiencies of repair, and excretion. The problem of the heterogenicity of the human population is addressed through several chapters that assess the availability and prospects of developing predictive animal models for normal humans, as well as selected potential high-risk groups. Other topics presented in this book include the biological basis of regulatory actions involving attempts to extrapolate from exceptionally high exposure levels to realistic values, especially carcinogens; an assessment of genotoxicity tests, their ability to predict carcinogenicity in whole animals, and the manner in which they should be used by regulatory agencies; birth defects; and predicting the risk of human teratogenesis. Principle of Animal Extrapolation is essential for environmental toxicologists. It also provides valuable information to biomedical scientists (especially those involved in drug development and testing) and regulatory personnel in agencies such as the EPA, the OSHA, the NIOSH, and the FDA.

Builds on the message of Sacred Cows and Golden Geese to understand why medical research on animals really harms humans.

This two-volume set presents a comprehensive description of laboratory animal genetics, diseases, health monitoring, nutrition, and the environmental impact on animal testing. It considers the ethics of animal experimentation through a complete review of European and North American legislation on the topic. It discusses alternatives to animal experiments, including the use of isolated organs, cell cultures, and computer simulations. The book also examines general methods, including experimental design and statistical evaluation, non-surgical and surgical techniques, anesthesia, and post-mortem examinations. Reviews of animal models for studying diseases of different organ systems, infectious diseases, cancer, and toxicology are featured as well.

The 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.

Biomedical research involving animals remains essential for the advancement of the medical, veterinary, agricultural, and biological sciences. Following in the footsteps of its predecessors, the Handbook of Laboratory Animal Science, Volume II, Third Edition: Animal Models explains in great detail the comparative considerations underlying the choic

This book will outline the strategies used in the investigation, characterization, management, and restoration and remediation for various contaminated sites. It will draw on real-world examples from across the globe to illustrate remediation techniques and discuss their applicability. It will provide guidance for the successful corrective action assessment and response programs for any type of contaminated land problem, and at any location. The systematic protocols presented will aid environmental professionals in managing contaminated land and associated problems more efficiently. This new edition will add twelve new chapters, and be fully updated and expanded throughout.

Animal Experimentation: Working Towards a Paradigm Change critically appraises current animal use in science and discusses ways in which we can contribute to a paradigm change towards human-biology based approaches.

LOCATE FREQUENTLY USED INFORMATION EASILY AND QUICKLY Working in the laboratory or office, you use a diverse assortment of basic information to design, conduct, and interpret toxicology studies and to perform risk assessments. The Second Edition of the best-selling Handbook of Toxicology gives you the information you need in a single referen

Scientific 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.