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Critical Contributions Of Primate Models For Biopharmaceutical Drug Development
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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.
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:
Author :Committee on Long-Term Care of Chimpanzees Publisher :National Academies Press ISBN 13 :0309591155 Total Pages :108 pages Book Rating :4.3/5 (95 download)
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.
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
Book Synopsis Pediatric Non-Clinical Drug Testing by : Alan M. Hoberman
Download or read book Pediatric Non-Clinical Drug Testing written by Alan M. Hoberman and published by John Wiley & Sons. This book was released on 2011-12-28 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.
Book Synopsis Challenges in Nonhuman Primate Research in the 21st Century by : Gerhard F. Weinbauer
Download or read book Challenges in Nonhuman Primate Research in the 21st Century written by Gerhard F. Weinbauer and published by Waxmann Verlag. This book was released on 2013 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: In continuation of the Covance Primate Symposium Series, the 19th Covance Primate Symposium took place in Münster on 23rd & 24th of May 2012. Altogether, 70 participants representing 43 organisations, gathered for this symposium. The 2012 Primate Symposium focussed on ?Challenges in Nonhuman Primate Research in the 21st Century?. The broad participation and the lively discussions during the symposium underlined the timeliness and importance of this topic. Expert speakers covered four major topics, i.e. biosimilars development: regulatory implications, key considerations and next steps, optimizing nonhuman primate use in nonclinical safety assessment, trends in nonhuman primate developmental & reproductive toxicology (DART) and juvenile toxicity evaluation, and relevance and importance of nonhuman primate models in regulatory toxicology. The development of biosimilar has taken up speed considerably and meanwhile needs to be considered a significant factor of potential drug development, yet there are still some uncertainties und guidelines are under development. With the increased focus on biopharmaceuticals and the associated increase for using nonhuman primates being the relevant animal model, it became necessary to optimize the use of this animal model, e.g. refine study designs and animals numbers but still execute meaningful preclinical studies. It appears that significant progress has been achieved in that context. In the area of nonhuman primate DART and juvenile toxicity evaluation, recent guideline changes had a major impact on species selection, and the experimental design plus the timing of these studies within the preclinical programmes. Finally, given the increasing regulations and justficiations of using nonhuman primates as experimental models. It is paramount to understand the essential and indispensable role that nonhuman primates can play in drug safety evaluation and medical drug development.
Author : Publisher :Waxmann Verlag ISBN 13 :3830971044 Total Pages :184 pages Book Rating :4.8/5 (39 download)
Download or read book written by and published by Waxmann Verlag. This book was released on with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Translational Medicine by : Joy A. Cavagnaro
Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Book Synopsis The Role of the Study Director in Nonclinical Studies by : William J. Brock
Download or read book The Role of the Study Director in Nonclinical Studies written by William J. Brock and published by John Wiley & Sons. This book was released on 2014-05-02 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
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.
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.
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
Book Synopsis Critical Needs for Research in Veterinary Science by : National Research Council
Download or read book Critical Needs for Research in Veterinary Science written by National Research Council and published by National Academies Press. This book was released on 2005-10-18 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research in veterinary science is critical for the health and well-being of animals, including humans. Food safety, emerging infectious diseases, the development of new therapies, and the possibility of bioterrorism are examples of issues addressed by veterinary science that have an impact on both human and animal health. However, there is a lack of scientists engaged in veterinary research. Too few veterinarians pursue research careers, and there is a shortage of facilities and funding for conducting research. This report identifies questions and issues that veterinary research can help to address, and discusses the scientific expertise and infrastructure needed to meet the most critical research needs. The report finds that there is an urgent need to provide adequate resources for investigators, training programs, and facilities involved in veterinary research.
Book Synopsis Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents by : National Research Council
Download or read book Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents written by National Research Council and published by National Academies Press. This book was released on 2006-08-07 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 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.
Book Synopsis Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel
Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
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.
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
