Author: C. Ray Greek
Publisher: A&C Black
ISBN: 9780826413987
Category : Nature
Languages : en
Pages : 308

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

Author: Edward J. Calabrese
Publisher: CRC Press
ISBN: 1351359037
Category : Science
Languages : en
Pages : 617

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Book Description
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.

Author: Jann Hau
Publisher: CRC Press
ISBN: 9780849343902
Category : Medical
Languages : en
Pages : 228

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Book Description
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.

Author:
Publisher:
ISBN:
Category : Evidence, Expert
Languages : en
Pages : 652

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Book Description

Author: Jann Hau
Publisher: CRC Press
ISBN: 1420084585
Category : Medical
Languages : en
Pages : 469

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Book Description
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

Author: National Research Council
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226

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Book Description
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.

Author: Fred Gifford
Publisher: Elsevier
ISBN: 0444517871
Category : Mathematics
Languages : en
Pages : 601

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Book Description
This volume covers a wide range of conceptual, epistemological and methodological issues in the philosophy of science raised by reflection upon medical science and practice. Several chapters examine such general meta-scientific concepts as discovery, reduction, theories and models, causal inference and scientific realism as they apply to medicine or medical science in particular. Some discuss important concepts specific to medicine (diagnosis, health, disease, brain death). A topic such as evidence, for instance, is examined at a variety of levels, from social mechanisms for guiding evidence-based reasoning such as evidence-based medicine, consensus conferences, and clinical trials, to the more abstract analysis of experimentation, inference and uncertainty. Some chapters reflect on particular domains of medicine, including psychiatry, public health, and nursing. The contributions span a broad range of detailed cases from the science and practice of medicine, as well as a broad range of intellectual approaches, from conceptual analysis to detailed examinations of particular scientific papers or historical episodes. Chapters view philosophy of medicine from quite different angles Considers substantive cases from both medical science and practice Chapters from a distinguished array of contributors

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470248475
Category : Medical
Languages : en
Pages : 1346

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Book Description
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 1220

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Book Description

Author: Glenn W. Suter II
Publisher: CRC Press
ISBN: 9780873718752
Category : Technology & Engineering
Languages : en
Pages : 564

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Book Description
Recently, environmental scientists have been required to perform a new type of assessment-ecological risk assessment. This is the first book that explains how to perform ecological risk assessments and gives assessors access to the full range of useful data, models, and conceptual approaches they need to perform an accurate assessment. It explains how ecological risk assessment relates to more familiar types of assessments. It also shows how to organize and conduct an ecological risk assessment, including defining the source, selecting endpoints, describing the relevant features of the receiving environment, estimating exposure, estimating effects, characterizing the risks, and interacting with the risk manager. Specific technical topics include finding and selecting toxicity data; statistical and mathematical models of effects on organisms, populations, and ecosystems; estimation of chemical fate parameters; modeling of chemical transport and fate; estimation of chemical uptake by organisms; and estimation, propagation, and presentation of uncertainty. Ecological Risk Assessment also covers conventional risk assessments, risk assessments for existing contamination, large scale problems, exotic organisms, and risk assessments based on environmental monitoring. Environmental assessors at regulatory agencies, consulting firms, industry, and government labs need this book for its approaches and methods for ecological risk assessment. Professors in ecology and other environmental sciences will find the book's practical preparation useful for classroom instruction. Environmental toxicologists and chemists will appreciate the discussion of the utility for risk assessment of particular toxicity tests and chemical determinations.