the nonhuman primate in nonclinical drug development and safety assessment

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The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment

Author : Joerg Bluemel
ISBN : 9780124171466
Genre : Medical
File Size : 35. 64 MB
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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

The Laboratory Nonhuman Primate

Author : Jeffrey D. Fortman
ISBN : 9781351643276
Genre : Medical
File Size : 44. 76 MB
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Extensively updated to include current literature, The Laboratory Nonhuman Primate, Second Edition, continues to serve as a quick reference source for technicians, caretakers, veterinarians, researchers, and students working with primates in biomedical research. It provides details on basic husbandry and covers biologic characteristics, regulatory compliance, common diseases, and anesthetic management. The text gives easy-to-follow descriptions of basic technical procedures including restraint, intubation, tuberculin skin testing, and collection of blood and urine samples. It also reviews advanced sampling procedures including collection of bone marrow, cerebrospinal fluid, bronchoalveolar lavage fluid, and rectal mucosal biopsy. The Laboratory Nonhuman Primate presents information in a clear, concise format to allow readers to incorporate concepts and techniques into the standard operating procedures of a facility.

Drug Discovery Toxicology

Author : J. Eric McDuffie
ISBN : 9781119053330
Genre : Medical
File Size : 48. 94 MB
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As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Challenges In Nonhuman Primate Research In The 21st Century

Author : Gerhard F. Weinbauer
ISBN : 9783830978398
Genre : Medical
File Size : 44. 89 MB
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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.

Nonhuman Primates In Biomedical Research

Author : Christian R. Abee
ISBN : 9780123978370
Genre : Science
File Size : 62. 26 MB
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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 Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information

Pediatric Non Clinical Drug Testing

Author : Alan M. Hoberman
ISBN : 9781118168257
Genre : Medical
File Size : 53. 70 MB
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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.

Immunotoxicology Strategies For Pharmaceutical Safety Assessment

Author : Danuta J. Herzyk
ISBN : 9780470386378
Genre : Medical
File Size : 33. 37 MB
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An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates Helps readers understand the significance of the methods and approaches to immunotoxicology testing Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing

Toxicologic Pathology

Author : Pritam S. Sahota
ISBN : 9781439872123
Genre : Medical
File Size : 69. 59 MB
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As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Safety Assessment presents a histopathologic description of lesions observed during drug development and discusses their implication in the drug development process. Divided into two sections, the book systematically assists pathologists in making a determination as to the origin and potential importance of a lesion and its relevance for assessing human risk. The first section includes eight "concept" chapters to orient pathologists in areas that are important for effective interaction with other pathologists as well as the many non-pathologists involved in drug development. The second section is made up of organ-based chapters, each including light microscopic and electron microscopic descriptions of pathological lesions, differential diagnoses, biological consequences, pathogenesis, mechanism of lesion formation, and the expected clinical pathology correlates. This volume presents critical information—both published and unpublished and gained through personal experience—to improve the quality of drug safety evaluation and to expedite and improve the efficiency of the process. This book is crafted to assist students, residents, and toxicologic pathologists in their early career phase by serving as a resource that can effectively be used as a ready reference next to the microscope. In addition, more experienced pathologists will find this volume to be invaluable during their assessments. The book is also a valuable reference for toxicologists to assist in understanding compound-related pathological findings and to provide background for working on a range of toxicological problems.

The Anthrax Vaccine Immunization Program What Have We Learned

Author : United States. Congress. House. Committee on Government Reform
ISBN : MINN:31951D01956738F
Genre : Anthrax
File Size : 76. 76 MB
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Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals

Author : Carrie Markgraf
ISBN : 9780124202160
Genre : Medical
File Size : 75. 14 MB
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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

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