Skip to main content

The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment

In Order to Read Online or Download The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book
Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard F. Weinbauer
Publisher : Academic Press
Release : 2015-03-12
ISBN : 9780124171442
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 Book
Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Release : 2015-03-13
ISBN : 012417146X
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 Book
Author : Gerhard F. Weinbauer,Friedhelm Vogel
Publisher : Waxmann Verlag
Release : 2013
ISBN : 3830978391
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 Book
Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publisher : John Wiley & Sons
Release : 2016-03-16
ISBN : 1119053323
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Immunotoxicology Strategies for Pharmaceutical Safety Assessment Book
Author : Danuta J. Herzyk,Jeanine L. Bussiere
Publisher : John Wiley & Sons
Release : 2008-11-21
ISBN : 0470386371
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals Book
Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Release : 2013-03-07
ISBN : 1118679385
Language : En, Es, Fr & De

GET BOOK

Book Description :

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: Includes an overview of biopharmaceuticals with information onregulation and methods of production Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.

Drug Safety Evaluation

Drug Safety Evaluation Book
Author : Shayne C. Gad
Publisher : Wiley-Interscience
Release : 2002-04-18
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity.

Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies Book
Author : Peter Greaves
Publisher : Elsevier Science Limited
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Impact Assessment of the Biomedical and Health Research Programme BIOMED 2

Impact Assessment of the Biomedical and Health Research Programme BIOMED 2 Book
Author : European Commission. Directorate General for Research
Publisher : Office for Official Publications of the European Communities
Release : 2002
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology Book
Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Release : 2018-09-05
ISBN : 0128123346
Language : En, Es, Fr & De

GET BOOK

Book Description :

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues. Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs

Primate Report

Primate Report Book
Author : Anonim
Publisher : Unknown
Release : 2005
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Primate Report book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Genetic Engineering Biotechnology News

Genetic Engineering   Biotechnology News Book
Author : Anonim
Publisher : Unknown
Release : 2007
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Genetic Engineering Biotechnology News book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Bone Toxicology

Bone Toxicology Book
Author : Susan Y. Smith,Aurore Varela,Rana Samadfam
Publisher : Springer
Release : 2017-09-27
ISBN : 3319561928
Language : En, Es, Fr & De

GET BOOK

Book Description :

The content of this book is intended to provide the toxicologist in drug development in the pharmaceutical and biotechnology industries with a broad understanding of bone and its interactions with other organ systems in safety assessments. The book is divided into three parts. The first part describes our current understanding of bone biology and its primary regulatory pathways. Additional chapters address regulatory and study design considerations for incorporating bone end points in toxicology studies, with special consideration being given to juvenile toxicology studies. This is intended to address recent regulatory requirements to evaluate skeletal development for drugs in development for pediatric populations. The second part of the book describes the principal techniques and methods used in bone research; understanding how these end-points are derived is fundamental to their appropriate application. These first two parts of the book provide the background and the means to develop the concepts in part three which describes bone and its interaction with other organ systems. The unique series of chapters in part three, contributed to by key leaders in their respective fields and in bone research, provides a comprehensive collective work. Although constantly evolving, the crosstalk and interaction of the skeleton with several organ systems is now recognized and well documented, such as for the reproductive system, muscle and kidney, while our understanding of the interaction with other organ systems, such as the immune system and CNS, is in its infancy. Recent work highlights the key role of the skeleton in the regulation of energy metabolism and the impact this has on research in metabolic diseases such as obesity and diabetes. The hope is that this book will enlighten many and encourage more to explore the impact of new compounds on the skeleton in the development of effective and safe drugs.

Environmental Chemical Exposures and Immune System Integrity

Environmental Chemical Exposures and Immune System Integrity Book
Author : Robert G. Tardiff
Publisher : Princeton Scientific Pub
Release : 1987
ISBN : 9780911131147
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Environmental Chemical Exposures and Immune System Integrity book written by Robert G. Tardiff, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Casarett Doull s Toxicology The Basic Science of Poisons Eighth Edition

Casarett   Doull s Toxicology  The Basic Science of Poisons  Eighth Edition Book
Author : Curtis Klaassen
Publisher : McGraw Hill Professional
Release : 2013-04-25
ISBN : 0071769226
Language : En, Es, Fr & De

GET BOOK

Book Description :

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"

Alternatives to Laboratory Animals

Alternatives to Laboratory Animals Book
Author : Anonim
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Alternatives to Laboratory Animals book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Casarett Doull s Toxicology The Basic Science of Poisons Eighth Edition

Casarett   Doull s Toxicology  The Basic Science of Poisons  Eighth Edition Book
Author : Louis J. Casarett,John Doull
Publisher : McGraw Hill Professional
Release : 2013-06-19
ISBN : 0071769234
Language : En, Es, Fr & De

GET BOOK

Book Description :

Casarett and Doull's has set the standard for toxicology reference texts for years, and is the market leading title to this day. It serves the general toxicology market, and is to the field what Goodman and Gilman is to pharmacology. The books are often purchased together, and form a knock-out punch along with our DiPiro textbook; combined, these three titles produce millions of dollars in revenue and more than 100,000 in unit sales. Casarett & Doull's is, in other words, one part of a triad that forms the best pharmacology/pharmacy/toxicology collection in all of medical publishing

AIDS Research and Human Retroviruses

AIDS Research and Human Retroviruses Book
Author : Anonim
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download AIDS Research and Human Retroviruses book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pharmacology and Pharmacologists

Pharmacology and Pharmacologists Book
Author : Oxford University Press
Publisher : Oxford University Press, USA
Release : 1981
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Pharmacology and Pharmacologists book written by Oxford University Press, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Teratology

Teratology Book
Author : Anonim
Publisher : Unknown
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Teratology book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.