May 9, 2021

Download Ebook Free The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment

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
Category : Medical
Total pages :716
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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

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
Category : Medical
Total pages :180
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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.

Drug Discovery Toxicology

Drug Discovery Toxicology
Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publisher : John Wiley & Sons
Release Date : 2016-03-22
Category : Medical
Total pages :584
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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

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
Author : Ali S. Faqi
Publisher : Academic Press
Release Date : 2016-11-03
Category : Medical
Total pages :986
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A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Drug Safety Evaluation

Drug Safety Evaluation
Author : Shayne C. Gad
Publisher : Wiley-Interscience
Release Date : 2002-04-18
Category : Medical
Total pages :1007
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Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity.

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
Category : Medical
Total pages :320
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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

Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Immunotoxicology Strategies for Pharmaceutical Safety Assessment
Author : Danuta J. Herzyk,Jeanine L. Bussiere
Publisher : John Wiley & Sons
Release Date : 2008-11-21
Category : Medical
Total pages :336
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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

Genetic Engineering & Biotechnology News

Genetic Engineering & Biotechnology News
Author : Anonim
Publisher : Unknown
Release Date : 2007
Category : Biotechnology
Total pages :129
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Impact Assessment of the Biomedical and Health Research Programme BIOMED 2

Impact Assessment of the Biomedical and Health Research Programme BIOMED 2
Author : European Commission. Directorate General for Research
Publisher : Office for Official Publications of the European Communities
Release Date : 2002
Category : Biologie - Recherche - Pays de l'Union européenne
Total pages :328
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The Biomedical and Health Research Programme 'BIOMED2' was in operation for four years between 1994-98 with a budget of 360 million ECU. The purpose of the programme was to support the competitiveness of the European scientific research base by participating in cost-sharing research in four key areas: pharmaceuticals, biomedical technology, brain research and human genome research. The overall objective was to promote general health improvements and the transfer of medical research results into medical practice. This publication seeks to assess the impact of BIOMED2 and to identify lessons to be learned for future programmes.

Primate Report

Primate Report
Author : Anonim
Publisher : Unknown
Release Date : 2005
Category : Laboratory animals
Total pages :129
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Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies
Author : Peter Greaves
Publisher : Elsevier Science Limited
Release Date : 1990
Category : Science
Total pages :824
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Histopathological assessment of tissue sections is an important componant of many preclinical studies which are conducted to support the safety and clinical development of novel therapeutic agents for use in the treatment of human diseases. The drug discovery process, aided by modern biotechnology, is now capable of generating highly potent, pharmacologically active agents which can give rise to quite unusual constellations of tissue pathology. The complexity and the number of histopathological findings in individual studies indicate the need for lucididy in descriptions and conclusions. In the light of these and other difficulties, this text is aimed towards bringing together into one volume a description of histopathological changes which relate to toxicity testing of therapeutic agents in the usual test species: rat, mouse, dog and non-human primate. This book is an excellent starting point for the analysis of drug-induced findings in toxicity studies.

Reviewing the Utility of Two Species in General Toxicology Related to Drug Development

Reviewing the Utility of Two Species in General Toxicology Related to Drug Development
Author : Anonim
Publisher : Unknown
Release Date : 2021
Category :
Total pages :129
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As part of the safety assessment of new drugs, the use of two species (a rodent and a nonrodent) for regulatory toxicology studies is the typical approach taken for small molecules. For biologics, species selection is dictated by pharmacological relevance, and single species toxicology packages (typically using the nonhuman primate) are common. The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research and the Association of the British Pharmaceutical Industry are collaborating on a project to review the utility of two species in regulatory toxicology studies, with the aim to explore whether there are wider circumstances when data from a single species could be sufficient to enable safe progression in humans. An international working group consisting of 37 representatives from pharmaceutical and biotechnology companies, contract research organizations, academia, and regulatory bodies is coordinating a large-scale data sharing exercise to examine the potential for changes in current practice to reduce the number of species used for nonclinical safety testing at different stages of development. The challenge will be to determine whether two species toxicology adds significant value or whether in some instances data from a single species are sufficient (across a broader range of molecules than is currently the case) without compromising human safety.

Environmental Chemical Exposures and Immune System Integrity

Environmental Chemical Exposures and Immune System Integrity
Author : Robert G. Tardiff
Publisher : Princeton Scientific Pub
Release Date : 1987
Category : Medical
Total pages :259
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Directory of American Research and Technology

Directory of American Research and Technology
Author : Anonim
Publisher : Unknown
Release Date : 1998
Category : Laboratories
Total pages :129
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Identifies non-government facilities active in commercial research, including development of products and processes. Arrangement is alphabetic, geographic, and by concept classification.

Casarett & Doull's Toxicology: The Basic Science of Poisons, Eighth Edition

Casarett & Doull's Toxicology: The Basic Science of Poisons, Eighth Edition
Author : Curtis Klaassen
Publisher : McGraw Hill Professional
Release Date : 2013-04-25
Category : Medical
Total pages :1473
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The most trusted all-in-one overview of the biomedical and environmental aspects of toxicology--NOW more complete, up-to-date, and in full color The world's leading and most authoritative textbook on poisons has more to offer students,toxicologists, and pharmacologists than ever before. Now in full color, and thoroughly revised, the eighth edition of Casarett & Doull's TOXICOLOGY: The Basic Science of Poisons not only delivers a comprehensive review of the essential components of toxicology, it offers the most up-to-date, revealing, and in-depth look at the systemic responses of toxic substance available anywhere. Combined with the latest thinking by the field's foremost scholars plus solid coverage of general principles, modes of action, and chemical-specific toxicity, this landmark text continues to set the standard for toxicology references. NEW to the Eighth Edition FULL-COLOR design to allow for a clearer interpretation of the basic components of toxicology featured throughout the text EXPANDED tables, illustrations, and other visuals are updated with state-of-the-art standards that makes this edition even more current and relevant DVD with image bank features all tables and illustrations from the text in presentation-ready format NEW CHAPTERS include "Toxic Effects of Calories" and "Toxic Effects of Nanoparticles"