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The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment

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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

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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

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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.

Biomedical Product and Materials Evaluation

Biomedical Product and Materials Evaluation Book
Author : P.V. Mohanan
Publisher : Woodhead Publishing
Release : 2022-01-22
ISBN : 012824173X
Language : En, Es, Fr & De

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Book Description :

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 aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Drug Discovery Toxicology

Drug Discovery Toxicology Book
Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publisher : John Wiley & Sons
Release : 2016-03-22
ISBN : 1119053390
Language : En, Es, Fr & De

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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

Nonhuman Primate Models in Preclinical Research

Nonhuman Primate Models in Preclinical Research Book
Author : Huifang Chen
Publisher : Unknown
Release : 2021
ISBN : 9781536194401
Language : En, Es, Fr & De

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Book Description :

"Due to the phylogenetic relationship and close genetic and biological similarities with humans, non-human primates (NHP) are regularly used in biomedical and behavioural research. However, because of their highly developed cognitive abilities and social skills, the use of these animals in biomedical research is debated more and more. Although it is acknowledged that in specific research areas NHP are still essential, it is recognized that the use of these animals can only be done under strict conditions under the most optimal welfare aspects. Welfare aspects include housing conditions, non-invasive methods and application of the 3Rs policy. Although many refinement methods have been described in nationally and internationally accepted guidelines on animal laboratory practice, recognition of the guidelines is unfortunately not universal. The present book covers a wide range of NHP models in preclinical research and welfare issues. The following chapters will cover: refinement of the use of NHP in biomedical research; NHP ethics and regulations in Europe; biological basis differences in the human and NHP; the major histocompatibility complex (MHC) immunology in NHP; stem cell biology in NHP; neuro and gliogenesis in an NHP ischemia stroke model; NHP models in autoimmune disease, organ transplantation and infectious disease research; viral diseases in NHP; NHP models in Parkinson's disease, in neurodegenerative disorders research and in cardio-cerebrovascular disease research; islet transplantation; ophthalmic diseases research and neurophysiology in NHP; transgenic engineering in NHP; NHP models of cancers; NHP models in respiratory disease research; NHP models in clinical and non-clinical pharmacology; NHP models in lung transplantation; and aging research in NHP. This book encapsulates a large volume of knowledge scientists have achieved in the field of nonhuman primate models in preclinical research. The editors have invited experts from the United States, Canada, and Europe to contribute 23 chapters in their respective fields of their expertise"--

Translational Medicine

Translational Medicine Book
Author : Joy A. Cavagnaro,Mary Ellen Cosenza
Publisher : CRC Press
Release : 2021-11-26
ISBN : 1000471829
Language : En, Es, Fr & De

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Book Description :

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.

The Laboratory Nonhuman Primate

The Laboratory Nonhuman Primate Book
Author : Jeffrey D. Fortman,Terry A. Hewett,Lisa C. Halliday
Publisher : CRC Press
Release : 2017-10-23
ISBN : 1351643274
Language : En, Es, Fr & De

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Book Description :

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.

Haschek and Rousseaux s Handbook of Toxicologic Pathology

Haschek and Rousseaux s Handbook of Toxicologic Pathology Book
Author : Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig,Brad Bolon
Publisher : Academic Press
Release : 2021-10-20
ISBN : 0128218290
Language : En, Es, Fr & De

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Book Description :

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 is an essential part of the most authoritative reference on toxicologic pathology for pathologists, toxicologists, research scientists, and regulators studying and making decisions on drugs, biologics, medical devices, and other chemicals, including agrochemicals and environmental contaminants. Provides new chapters on digital pathology, juvenile pathology, in vitro/in vivo correlation, big data technologies and in-depth discussion of timely topics in the area of toxicologic pathology Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology Features hundreds of full-color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

An Introduction to Interdisciplinary Toxicology

An Introduction to Interdisciplinary Toxicology Book
Author : Carey N. Pope,Jing Liu
Publisher : Academic Press
Release : 2020-02-18
ISBN : 0128136030
Language : En, Es, Fr & De

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Book Description :

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, further reading, study questions, and other learning features are also included. The book allows students to concurrently learn concepts in both biomedical and environmental toxicology fields, thus better equipping them for the many career opportunities toxicology provides. This book will also be useful to those wishing to reference how disciplines interact within the broad field of toxicology. Covers major topics and newer areas in toxicology, including nanotoxicology, Tox21, epigenetic toxicology, and organ-specific toxicity Includes a variety of perspectives to give a complete understanding of toxicology Written by specialists within each subject area, e.g., a chemical engineer, to ensure concepts are clearly explained

Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance Book
Author : Sabrina Nour,Gilles Plourde
Publisher : Academic Press
Release : 2018-10-17
ISBN : 012816381X
Language : En, Es, Fr & De

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Book Description :

Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance

Drug Safety Evaluation

Drug Safety Evaluation Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2016-12-01
ISBN : 111909741X
Language : En, Es, Fr & De

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Book Description :

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 to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology Book
Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Release : 2018-08
ISBN : 9780128122068
Language : En, Es, Fr & De

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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

Model Organisms for Microbial Pathogenesis Biofilm Formation and Antimicrobial Drug Discovery

Model Organisms for Microbial Pathogenesis  Biofilm Formation and Antimicrobial Drug Discovery Book
Author : Busi Siddhardha,Madhu Dyavaiah,Asad Syed
Publisher : Springer Nature
Release : 2020-03-28
ISBN : 9811516952
Language : En, Es, Fr & De

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Book Description :

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 therapy in order to develop novel therapeutic strategies. In turn, the second part of the book presents a comparative analysis of various animal models to help readers understand microbial pathogenesis, host-pathogen interactions, anti-microbial drug discovery, anti-biofilm therapeutics, and treatment regimes. Given its scope, the book represents a valuable asset for microbiologists, biotechnologists, medical professionals, drug development researchers, and pharmacologists alike.

Toxicologic Pathology for Non Pathologists

Toxicologic Pathology for Non Pathologists Book
Author : Thomas J. Steinbach,Daniel J. Patrick,Mary Ellen Cosenza
Publisher : Springer Nature
Release : 2019-10-31
ISBN : 1493997777
Language : En, Es, Fr & De

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Book Description :

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 pathology concepts that include fundamental vocabulary and the basics of pathophysiological processes, along with numerous chapters devoted to pathology in specific organ systems as well as topics such as biomarkers, correlation of clinical pathology endpoints (chemistry and hematology) with microscopic changes, and well-known pathology findings for classes of toxic substances. Authoritative, practical, and comprehensive, Toxicologic Pathology for Non-Pathologists aims to help non-pathologists understand, converse in, and apply a basic understanding of pathology in their day-to-day careers.

Immunopathology in Toxicology and Drug Development

Immunopathology in Toxicology and Drug Development Book
Author : George A. Parker
Publisher : Springer
Release : 2017-03-27
ISBN : 3319473859
Language : En, Es, Fr & De

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Book Description :

This book provides a fundamental understanding of immunopathology and immunopathologic processes, with particular attention to nonclinical toxicology studies. Chapters provide organ system–based summaries of spontaneous pathology and common responses to xenobiotics. A companion volume, Immunopathology in Toxicology and Drug Development: Volume 1, Immunobiology, Investigative Techniques, and Special Studies, offers an overview of general immunobiology, cells of the immune system, signaling and effector molecules, and immunopathology assays. These informative and strategic books were created in response to the large segment of drug development that focuses on chronic diseases, many of which involve alterations to the immune system. Therapies that target these diseases commonly involve some form of immunomodulation. As a result, the two volumes of Immunopathology in Toxicology and Drug Development are critical texts for individuals involved in diverse aspects of drug development. Readers will acquire a thorough understanding of immunopathology for detection and accurate interpretation of pathologic effects of xenobiotics on the immune system.

Schalm s Veterinary Hematology

Schalm s Veterinary Hematology Book
Author : Marjory B. Brooks,Kendal E. Harr,Davis M. Seelig,K. Jane Wardrop,Douglas J. Weiss
Publisher : John Wiley & Sons
Release : 2022-02-24
ISBN : 1119500524
Language : En, Es, Fr & De

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Book Description :

SCHALM’S VETERINARY HEMATOLOGY An updated guide to veterinary hematology with expanded coverage on a variety of topics The revised seventh edition of Schalm’s Veterinary Hematology is updated to provide a comprehensive review of all topics related to disorders of the blood in animals. Designed as a gold-standard reference, this text covers a wide range of species in both confined and free-range populations, reflects the most recent trends in hematology diagnostics, and discusses recent advances in traditional techniques. Edited and written by an international team of experts in the field, the book represents an accessible yet in-depth resource for information on veterinary hematology. The new edition includes a hemolymphatic tissue section that covers current understanding of basic science and the species-specific hematology section is further expanded from previous editions. New chapters address emerging topics in hematology, and existing chapters have been revised and rearranged to improve readability and simplify access to the material. This seventh edition: Updates the most complete reference on veterinary hematology across species Contains a new section on basic biology of hemolymphatic tissues Expands coverage of species-specific hematology Presents new and emerging topics in blood disorders and diagnostic techniques Features a reorganized contents list for an integrated, easy to use reference Written for veterinary clinical pathologists and residents, diagnostic laboratory staff, internists, and specialists, Schalm’s Veterinary Hematology is the most comprehensive and up-to-date reference on the topic.

Essentials of Laboratory Animal Science Principles and Practices

Essentials of Laboratory Animal Science  Principles and Practices Book
Author : P. Nagarajan,Ramachandra Gudde,Ramesh Srinivasan
Publisher : Springer Nature
Release : 2021-07-23
ISBN : 981160987X
Language : En, Es, Fr & De

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Book Description :

This book comprehensively reviews the anatomy, physiology, genetics and pathology of laboratory animals as well as the principles and practices of using laboratory animals for biomedical research.It covers the design of buildings used for laboratory animals, quality control of laboratory animals, and toxicology, and discusses various animal models used for human diseases. It also highlights aspects, such as handling and restraint and administration of drugs, as well as breeding and feeding of laboratory animals, and provides guidelines for developing meaningful experiments using laboratory animals.Further, the book discusses various alternatives to animal experiments for drug and chemical testing, including their advantages over the current approaches. Lastly, it examines the potential effect of harmful pathogens on the physiology of laboratory animals and discusses the state of art in in vivo imaging techniques.The book is a useful resource for research scientists, laboratory animal veterinarians, and students of laboratory animal medicine.

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals Book
Author : Carrie Markgraf,Thomas Hudzik,David Compton
Publisher : Academic Press
Release : 2015-07-14
ISBN : 0124202160
Language : En, Es, Fr & De

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Book Description :

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

Toxicology of the Gastrointestinal Tract Second Edition

Toxicology of the Gastrointestinal Tract  Second Edition Book
Author : Shayne Cox Gad
Publisher : CRC Press
Release : 2018-10-26
ISBN : 042978144X
Language : En, Es, Fr & De

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Book Description :

The gastrointestinal tract is the most important of the three major routes of entry (and clearance) of xenobiotics and biologic entities into the bodies of mammals. As such, it is also the major route for administration of pharmaceuticals to humans. Gastrointestinal Toxicology, Second Edition describes the mechanism for entry and clearance of xenobiotics, as well as the barriers, immunologic and metabolic issues, and functions present in the GI tract. Appearing in this volume are also considerations of the microbiome and its actions and influence on the function of the GI tract and on the toxicity and pharmacodynamics of ingested substances (including nutrients, toxins, and therapeutics). These fifteen chapters written by experienced experts in the field address methods to evaluate GI function; specifics of GI function and toxicity assessment in canines and minipigs; classes of compounds with their toxicity; species differences; and the toxicity (and promise) of nanoparticles. Those needing to understand the structure, function, and methods of studying the GI tract will find this volume a singular source of reference.

Nonclinical Safety Assessment

Nonclinical Safety Assessment Book
Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Release : 2013-04-29
ISBN : 0470745916
Language : En, Es, Fr & De

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Book Description :

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 accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.