The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

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  • Publisher : Academic Press
  • Release : 12 March 2015
  • ISBN : 0124171443
  • Page : 716 pages
  • Rating : 4.5/5 from 103 voters

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Annotation This reference compiles 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, it provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing.

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
  • Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard F. Weinbauer
  • Publisher : Academic Press
  • Release Date : 2015-03-12
  • ISBN : 0124171443
GET THIS BOOKThe Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Annotation This reference compiles 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, it provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing.

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
  • Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
  • Publisher : Academic Press
  • Release Date : 2015-03-13
  • ISBN : 9780124171466
GET THIS BOOKThe Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

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

Challenges in Nonhuman Primate Research in the 21st Century

Challenges in Nonhuman Primate Research in the 21st Century
  • Author : Gerhard F. Weinbauer,Friedhelm Vogel
  • Publisher : Waxmann Verlag
  • Release Date : 2013
  • ISBN : 9783830978398
GET THIS BOOKChallenges in Nonhuman Primate Research in the 21st Century

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,

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals
  • Author : Carrie Markgraf,Thomas Hudzik,David Compton
  • Publisher : Academic Press
  • Release Date : 2015-07-14
  • ISBN : 9780124202160
GET THIS BOOKNonclinical Assessment of Abuse Potential for New Pharmaceuticals

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

Nonhuman Primate Welfare

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  • Author : Lauren M. Robinson,Alexander Weiss
  • Publisher : Springer Nature
  • Release Date : 2023-02-01
  • ISBN : 9783030827083
GET THIS BOOKNonhuman Primate Welfare

This volume reviews the broad topic of welfare in nonhuman primates under human care. Chapters detail the history of primates in captivity, ethical and legal issues surrounding the use of nonhuman primates as entertainment or in research, the different approaches that welfare are measured, and how housing, enrichment, and other conditions can foster or degrade welfare. Since humans began keeping nonhuman primates we have made vast strides in understanding their cognitive abilities, strong social bonds, vibrant personalities, and their capacity

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  • Publisher : John Wiley & Sons
  • Release Date : 2016-03-22
  • ISBN : 9781119053392
GET THIS BOOKDrug Discovery Toxicology

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

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  • Author : P.V. Mohanan
  • Publisher : Woodhead Publishing
  • Release Date : 2022-01-22
  • ISBN : 9780128241738
GET THIS BOOKBiomedical Product and Materials Evaluation

Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical

The Laboratory Nonhuman Primate

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  • Author : Jeffrey D. Fortman,Terry A. Hewett,Lisa C. Halliday
  • Publisher : CRC Press
  • Release Date : 2017-10-23
  • ISBN : 9781351643276
GET THIS BOOKThe Laboratory Nonhuman Primate

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

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  • Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
  • Publisher : John Wiley & Sons
  • Release Date : 2013-04-29
  • ISBN : 9780470745915
GET THIS BOOKNonclinical Safety Assessment

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally

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  • Author : Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig,Brad Bolon
  • Publisher : Academic Press
  • Release Date : 2021-10-20
  • ISBN : 9780128218297
GET THIS BOOKHaschek and Rousseaux's Handbook of Toxicologic Pathology

Haschek and Rousseaux's Handbook of Toxicologic Pathology: Volume 1: Principles and Practice of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. Volume 1 of the Fourth Edition covers the practice of toxicologic pathology in three parts: Principles of Toxicologic Pathology, Methods in Toxicologic Pathology, and the Practice of Toxicologic Pathology. Completely revised with a number of new chapters, Volume 1 of the Handbook of Toxicologic Pathology

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  • Author : Joy A. Cavagnaro,Mary Ellen Cosenza
  • Publisher : CRC Press
  • Release Date : 2021-11-26
  • ISBN : 9781000471823
GET THIS BOOKTranslational Medicine

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

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  • Publisher : Academic Press
  • Release Date : 2020-02-18
  • ISBN : 9780128136034
GET THIS BOOKAn Introduction to Interdisciplinary Toxicology

An Introduction to Interdisciplinary Toxicology: From Molecules to Man integrates the various aspects of toxicology, from “simple molecular systems, to complex human communities, with expertise from a spectrum of interacting disciplines. Chapters are written by specialists within a given subject, such as a chemical engineer, nutritional scientist, or a microbiologist, so subjects are clearly explained and discussed within the toxicology context. Many chapters are comparative across species so that students in ecotoxicology learn mammalian toxicology and vice versa. Specific citations,

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  • Publisher : John Wiley & Sons
  • Release Date : 2016-12-01
  • ISBN : 9781119097419
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This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material

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  • Release Date : 2020-03-28
  • ISBN : 9789811516955
GET THIS BOOKModel Organisms for Microbial Pathogenesis, Biofilm Formation and Antimicrobial Drug Discovery

This book provides essential insights into microbial pathogenesis, host-pathogen interactions, and the anti-microbial drug resistance of various human pathogens on the basis of various model organisms. The initial sections of the book introduce readers to the mechanisms of microbial pathogenesis, host-pathogen interactions, anti-microbial drug resistance, and the dynamics of biofilm formation. Due to the emergence of various microbial resistant strains, it is especially important to understand the prognosis for microbial infections, disease progression profiles, and mechanisms of resistance to antibiotic

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  • Publisher : Springer Nature
  • Release Date : 2019-10-31
  • ISBN : 9781493997770
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This extensive volume began as a short course primarily geared toward toxicologists who want to expand their understanding of toxicologic pathology in order to be better study directors while also proving to be of great interest to other drug development scientists and regulatory reviewers. The overall goal is to help non-pathologists understand, contextualize, and communicate the pathology data and interpretations from the study pathologist in a practical and usable format. Within the book, readers will find an overview of general