Primate Models in Pharmaceutical Drug Development

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Publisher :
ISBN 13 : 9783830912330
Total Pages : 197 pages
Book Rating : 4.9/5 (123 download)

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Book Synopsis Primate Models in Pharmaceutical Drug Development by : Rainhart Korte

Download or read book Primate Models in Pharmaceutical Drug Development written by Rainhart Korte and published by . This book was released on 2002 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

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Publisher : Academic Press
ISBN 13 : 012417146X
Total Pages : 716 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by : Joerg Bluemel

Download or read book The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment written by Joerg Bluemel and published by Academic Press. This book was released on 2015-03-13 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

Critical Contributions of Primate Models for Biopharmaceutical Drug Development

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Publisher : Waxmann Verlag
ISBN 13 : 9783830921042
Total Pages : 184 pages
Book Rating : 4.9/5 (21 download)

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Book Synopsis Critical Contributions of Primate Models for Biopharmaceutical Drug Development by : Gerhard F. Weinbauer

Download or read book Critical Contributions of Primate Models for Biopharmaceutical Drug Development written by Gerhard F. Weinbauer and published by Waxmann Verlag. This book was released on 2008 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In continuation of the Covance Primate Symposium Series, the 17th Covance Primate Symposium took place in Münster during April 16 and 17, 2008. Altogether, 131 participants -- the largest attendance so far -- representing 13 countries and 56 organisations assembled for this symposium. The 2008 Primate Symposium focussed on 'Critical Contributions of Primate Models for Biopharmaceutical Drug Development'. This is obviously a very timely topic since numerous biopharmaceuticals, in particular monoclonal antibodies, are in preclinical development and, in many instances, nonhuman primates represent the relevant model. Also, there are efforts, at least in Europe, to substantially change the environmental conditions for primates in research which will also impact pharmaceutical drug development. Beyond this, current topics such as developmental and juvenile toxicity testing and the perspectives of stem cell-derived therapeutics were also covered. In general, it is assumed that the demand for research on nonhuman primates in preclinical development will increase over the coming years. Expert speakers discussed four topics in particular, i.e.:stem cell-derived therapeutics as a potential new horizon for new therapeutic drugs; the European environment for primate research and whether this presents a barrier or rather an opportunity; new approaches for developmental and juvenile toxicity testing in nonhuman primates; and current challenges in biopharmaceutical drug development."--Back cover.

In vivo Models for Drug Discovery

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Publisher : John Wiley & Sons
ISBN 13 : 3527333282
Total Pages : 600 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis In vivo Models for Drug Discovery by : José Miguel Vela

Download or read book In vivo Models for Drug Discovery written by José Miguel Vela and published by John Wiley & Sons. This book was released on 2014-08-11 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: This one-stop reference is the first to present the complete picture -- covering all relevant organisms, from single cells to mammals, as well as all major disease areas, including neurological disorders, cancer and infectious diseases. Addressing the needs of the pharmaceutical industry, this unique handbook adopts a broad perspective on the use of animals in the early part of the drug development process, including regulatory rules and limitations, as well as numerous examples from real-life drug development projects. After a general introduction to the topic, the expert contributors from research-driven pharmaceutical companies discuss the basic considerations of using animal models, including ethical issues. The main part of the book systematically surveys the most important disease areas for current drug development, from cardiovascular to endocrine disorders, and from infectious to neurological diseases. For each area, the availability of animal models for target validation, hit finding and lead profiling is reviewed, backed by numerous examples of both successes and failures among the use of animal models. The whole is rounded off with a discussion of perspectives and challenges. Key knowledge for drug researchers in industry as well as academia.

Animal and Translational Models for CNS Drug Discovery

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Publisher : Academic Press
ISBN 13 : 0080920411
Total Pages : 1367 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Animal and Translational Models for CNS Drug Discovery by : Robert A. McArthur

Download or read book Animal and Translational Models for CNS Drug Discovery written by Robert A. McArthur and published by Academic Press. This book was released on 2008-11-27 with total page 1367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal and Translational Models for CNS Drug Discovery combines the experience of academic, clinical and pharmaceutical neuroscientists in a unique collaborative approach to provide a greater understanding of the relevance of animal models of neuropsychiatric disorders and their role as translational tools for the discovery of CNS drugs being developed for the treatment of these disorders. The focus of this three-volume series of essays is to present a consensual picture of the translational value of animal models from leading experts actively involved in the use of animal models for understanding fundamental neurobiology of CNS disorders and the application of this knowledge to CNS drug discovery, and clinical investigators involved in clinical trials, drug development and eventual registration of novel pharmaceuticals. Each volume of the Animal and Translational Models for CNS Drug Discovery series is dedicated to the development and use of animal models in key therapeutic areas in psychiatric, neurologic and reward deficit disorders. Each volume has introductory chapters expressing the view of the role and relevance of animal models for CNS drug discovery and development from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in relevant therapeutic areas and discusses the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Each volume is available for purchase individually.

Primate Models of Children's Health and Developmental Disabilities

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Publisher : Academic Press
ISBN 13 : 9780080554068
Total Pages : 472 pages
Book Rating : 4.5/5 (54 download)

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Book Synopsis Primate Models of Children's Health and Developmental Disabilities by : Thomas Burbacher

Download or read book Primate Models of Children's Health and Developmental Disabilities written by Thomas Burbacher and published by Academic Press. This book was released on 2011-10-10 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rate of neurodevelopmental disabilities, including autism, mental retardation, hearing loss and attention deficit hyperactivity disorder is rising in the United States. Although estimates of the prevalence of these disorders vary, figures from the CDC indicate that 4% of all school age children are developmentally disabled. During infancy, many important milestones in behavioral development are shared between human and nonhuman primates. Learning more about the causes of abnormal development in monkeys has provided important insights into the mechanisms underlying neurodevelopmental disabilities in human infants. This book documents the latest research not commonly found in other references, and provides a comprehensive look at the results from decades of work with nonhuman primates as it relates to child development and disability. Includes hot topics such as early chemical exposures, immunological influences on development, low birth weight, endocrine disrupters, pediatric AIDS, origin of childhood psychopathologies and assisted reproductive technology Represents the significant body of work accumulated since funding for research on developmental disabilities has increased substantially in recent years

Chimpanzees in Research

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Publisher : National Academies Press
ISBN 13 : 0309591155
Total Pages : 108 pages
Book Rating : 4.3/5 (95 download)

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Book Synopsis Chimpanzees in Research by : Committee on Long-Term Care of Chimpanzees

Download or read book Chimpanzees in Research written by Committee on Long-Term Care of Chimpanzees and published by National Academies Press. This book was released on 1997-09-01 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chimpanzees in biomedical and behavioral research constitute a national resource that has been valuable in addressing national health needs. Facilities that house chimpanzees owned and supported by the National Institutes of Health (NIH) have successfully met the research requirements of the scientific community. The captive chimpanzee population in the United States has grown substantially, particularly over the last decade. That growth is due primarily to the success of the NIH-sponsored Chimpanzee Breeding and Research Program, which achieved the birth numbers thought necessary to meet the projected needs of biomedical research. However, the expected level of use of the chimpanzee model in biomedical research did not materialize, and that has created a complex problem that threatens both the availability of chimpanzees for research in the future and the infrastructure required to ensure the well-being of captive chimpanzees used in biomedical research. Because the present system is fragmented, it is impossible to formulate an accurate overview of the size and nature of the chimpanzee population. But, if the chimpanzee is to continue to be used in biomedical research responsibly, effectively, and cost-effectively, we must be able to oversee, track, and coordinate the maintenance and use of chimpanzees and to control the size of the population. To assess the long-range situation and to develop, implement, and monitor the application of policies for the proper use and care of chimpanzees, an authoritative, centralized oversight structure is imperative. Once it is in place, it will be possible to refine and implement this report's recommendations.

Animal Models of Pain

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Publisher : Humana Press
ISBN 13 : 9781607618799
Total Pages : 0 pages
Book Rating : 4.6/5 (187 download)

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Book Synopsis Animal Models of Pain by : Chao Ma

Download or read book Animal Models of Pain written by Chao Ma and published by Humana Press. This book was released on 2010-10-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the loss of work days, the price of health care and payments for compensation, litigation, and malpractice, and the overwhelming cost of human suffering, chronic pain syndromes affect humanity enormously on both an economic and personal level. In Animal Models of Pain, expert investigators in the field provide a consolidated review of the current state of pain research by capturing the diversity of animal models that are used to investigate pain mechanisms, which range from surgical incision to mechanical compression and from spinal cord injury to cutaneous/local inflammation and beyond. As a volume in the respected Neuromethods series, this book delivers its vital content through detailed descriptions of a wide variety of step-by-step laboratory methods. Authoritative and cutting-edge, Animal Models of Pain seeks to lead scientists closer to the ultimate goal of improving the quality of life and relieving the unbearable burden of chronic pain for millions of people throughout the world.

Animal and Translational Models for CNS Drug Discovery, 3 Vols. Set

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Publisher :
ISBN 13 : 9780123738615
Total Pages : pages
Book Rating : 4.7/5 (386 download)

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Book Synopsis Animal and Translational Models for CNS Drug Discovery, 3 Vols. Set by : Robert A. McArthur

Download or read book Animal and Translational Models for CNS Drug Discovery, 3 Vols. Set written by Robert A. McArthur and published by . This book was released on 2008-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Animal and Translational Models for CNS Drug Discovery: Neurological disorders

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (229 download)

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Book Synopsis Animal and Translational Models for CNS Drug Discovery: Neurological disorders by : Robert A. McArthur

Download or read book Animal and Translational Models for CNS Drug Discovery: Neurological disorders written by Robert A. McArthur and published by . This book was released on 2008 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Chimpanzees in Biomedical and Behavioral Research

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Publisher : National Academies Press
ISBN 13 : 0309220394
Total Pages : 200 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Chimpanzees in Biomedical and Behavioral Research by : National Research Council

Download or read book Chimpanzees in Biomedical and Behavioral Research written by National Research Council and published by National Academies Press. This book was released on 2012-01-05 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.

Nonhuman Primates in Biomedical Research

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Publisher : Academic Press
ISBN 13 : 0123978386
Total Pages : 868 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Nonhuman Primates in Biomedical Research by : Christian R. Abee

Download or read book Nonhuman Primates in Biomedical Research written by Christian R. Abee and published by Academic Press. This book was released on 2012-06-07 with total page 868 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The Diseases volume provides thorough reviews of naturally occurring diseases of nonhuman primates, with a section on biomedical models reviewing contemporary nonhuman primate models of human diseases. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in bioledical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information Includes four color images throughout

New Approaches to Drug Discovery

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Publisher : Springer
ISBN 13 : 3319289144
Total Pages : 341 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis New Approaches to Drug Discovery by : Ulrich Nielsch

Download or read book New Approaches to Drug Discovery written by Ulrich Nielsch and published by Springer. This book was released on 2016-03-30 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume gives an overview of state of the art technologies and future developments in the field of preclinical pharmaceutical research. A balanced mix of experts from academia and industry give insight in selected new developments in the drug discovery pathway. The topics cover the different parts of the drug discovery process, starting with new developments in the target identification and validation area. The lead generation part as a next step focuses on the requirements and technologies to identify new small molecules as lead compounds for further optimization; in a second section the technologies to identify biologics as leads are addressed. The final part focuses on the pharmacological models and technologies to characterize new compounds and the impact of biomarkers to facilitate the transfer of drug candidates into the development phase.

Use of Laboratory Animals in Biomedical and Behavioral Research

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Publisher : National Academies Press
ISBN 13 : 0309038391
Total Pages : 113 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Use of Laboratory Animals in Biomedical and Behavioral Research by : National Research Council

Download or read book Use of Laboratory Animals in Biomedical and Behavioral Research written by National Research Council and published by National Academies Press. This book was released on 1988-02-01 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific experiments using animals have contributed significantly to the improvement of human health. Animal experiments were crucial to the conquest of polio, for example, and they will undoubtedly be one of the keystones in AIDS research. However, some persons believe that the cost to the animals is often high. Authored by a committee of experts from various fields, this book discusses the benefits that have resulted from animal research, the scope of animal research today, the concerns of advocates of animal welfare, and the prospects for finding alternatives to animal use. The authors conclude with specific recommendations for more consistent government action.

Animal and Translational Models for CNS Drug Discovery: Reward deficit disorders

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (229 download)

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Book Synopsis Animal and Translational Models for CNS Drug Discovery: Reward deficit disorders by : Robert A. McArthur

Download or read book Animal and Translational Models for CNS Drug Discovery: Reward deficit disorders written by Robert A. McArthur and published by . This book was released on 2008 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Preclinical Safety Evaluation of Biopharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 1118679385
Total Pages : 1012 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Preclinical Safety Evaluation of Biopharmaceuticals by : Joy A. Cavagnaro

Download or read book Preclinical Safety Evaluation of Biopharmaceuticals written by Joy A. Cavagnaro and published by John Wiley & Sons. This book was released on 2013-03-07 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

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Publisher : Academic Press
ISBN 13 : 0124202160
Total Pages : 320 pages
Book Rating : 4.1/5 (242 download)

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Book Synopsis Nonclinical Assessment of Abuse Potential for New Pharmaceuticals by : Carrie Markgraf

Download or read book Nonclinical Assessment of Abuse Potential for New Pharmaceuticals written by Carrie Markgraf and published by Academic Press. This book was released on 2015-07-14 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy