Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies
Author: Peter Greaves
Publsiher: Academic Press
Total Pages: 886
Release: 2011-11-22
ISBN 10: 0444538569
ISBN 13: 9780444538567
Language: EN, FR, DE, ES & NL

Histopathology of Preclinical Toxicity Studies Book Review:

Chapter 1: Introduction -- Chapter 2: Integumentary System -- -- Skin and subcutaneous tissue -- Chapter 3: Mammary Gland -- Chapter 4: Haemopoietic and Lymphatic Systems -- -- Blood/bone marrow -- -- Lymphoid system -- -- Lymph nodes -- -- Spleen -- -- Thymus -- -- Lymphoreticular neoplasms -- Chapter 5: Musculoskeletal System -- -- Bone -- -- Joints -- -- Skeletal muscle -- Chapter 6: Respiratory Tract -- -- Nose, nasal sinuses, nasopharynx and pharynx -- -- Larynx and trachea -- -- Bronchi and lungs -- Chapter 7: Cardiovascular System -- -- Heart and pericardium -- -- Systemic blood vessels -- -- Pulmonary blood vessels -- Chapter 8: Gastrointestinal tract -- -- Forestomach -- -- Stomach (glandular) -- -- Small intestine -- -- Large intestine -- Chapter 9: Liver and Pancreas -- -- Liver -- -- Bile ducts, biliary system -- -- Pancreas -- Chapter 10: Urinary System -- -- Kidney -- -- Urinary bladder -- Chapter 11: Male Genital Tract -- -- Prostate gland -- -- Epididymis -- -- Testis -- Chapter 12: Female Genital Tract -- -- Vagina -- -- Cervix -- -- Uterus -- -- Ovary -- Chapter 13: Endocrine System -- -- Pituitary gland -- -- Adrenal gland -- -- Thyroid gland -- -- Parathyroid gland -- Chapter 14: Nervous System and Special Sense Organs -- -- Brain -- -- Spinal cord, spinal nerve roots, peripheral nerves -- -- Eye -- -- Ear -- Subject index

Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies
Author: Peter Greaves
Publsiher: Elsevier Science Limited
Total Pages: 824
Release: 1990
ISBN 10:
ISBN 13: UOM:39015021816627
Language: EN, FR, DE, ES & NL

Histopathology of Preclinical Toxicity Studies Book Review:

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.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author: Ali S. Faqi
Publsiher: Academic Press
Total Pages: 885
Release: 2012-11-16
ISBN 10: 0123878152
ISBN 13: 9780123878151
Language: EN, FR, DE, ES & NL

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book Review:

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

Background Lesions in Laboratory Animals E Book

Background Lesions in Laboratory Animals E Book
Author: Elizabeth Fiona McInnes
Publsiher: Elsevier Health Sciences
Total Pages: 256
Release: 2011-10-24
ISBN 10: 0702049247
ISBN 13: 9780702049248
Language: EN, FR, DE, ES & NL

Background Lesions in Laboratory Animals E Book Book Review:

Background Lesions in Laboratory Animals will be an invaluable aid to pathologists needing to recognize background and incidental lesions while examining slides taken from laboratory animals in acute and chronic toxicity studies, or while examining exotic species in a diagnostic laboratory. It gives clear descriptions and illustrations of the majority of background lesions likely to be encountered. Many of the lesions covered are unusual and can be mistaken for treatment-related findings in preclinical toxicity studies. The Atlas has been prepared with contributions from experienced toxicological pathologists who are specialists in each of the laboratory animal species covered and who have published extensively in these areas. over 600 high-definition, top-quality color photographs of background lesions found in rats, mice, dogs, minipigs, non-human primates, hamsters, guinea pigs and rabbits a separate chapter on lesions in the reproductive systems of all laboratory animals written by Dr Dianne Creasy, a world expert on testicular lesions in laboratory animals a chapter on common artifacts that may be observed in histological glass slides extensive references to each lesion described aging lesions encountered in all laboratory animal species, particularly in rats in mice which are used for carcinogenicity studies

Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies
Author: Peter Greaves
Publsiher: Elsevier
Total Pages: 960
Release: 2007-03-23
ISBN 10: 9780080471303
ISBN 13: 0080471307
Language: EN, FR, DE, ES & NL

Histopathology of Preclinical Toxicity Studies Book Review:

This work covers effectively all aspects of drug-induced pathology that may be encountered within preclinical toxicity studies. It fills a gap in the pathology literature relating to the preclinical safety assessment of new medicines. It systematically describes, in one volume, both spontaneous and drug induced pathology on an organ by organ basis. Information relevant to understanding the nature of pathological changes in pre-clinical studies and assessment of their relevance to the clinical investigation of new drugs is also covered. Numerous colour photographs are included that highlight and embellish the histopathological features that are described. It also contains many pertinent references to both human and animal pathology forming an essential basis for the assessment of drug-induced pathology. NEW TO THE THIRD EDITION: * Covers drug induced pathology in preclinical (animal) studies and their relevance for patients or volunteers in clinical studies * General comments to each chapter about the relevance of pathological findings to humans * Provides essential information that can help decide the relevance of particular lesions for patients

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
Author: Ali S. Faqi
Publsiher: Academic Press
Total Pages: 986
Release: 2016-11-03
ISBN 10: 0128036214
ISBN 13: 9780128036211
Language: EN, FR, DE, ES & NL

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book Review:

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

Atlas of Experimental Toxicological Pathology

Atlas of Experimental Toxicological Pathology
Author: C. Gopinath,D. Prentice,D.J. Lewis
Publsiher: Springer Science & Business Media
Total Pages: 170
Release: 2012-12-06
ISBN 10: 9400931891
ISBN 13: 9789400931893
Language: EN, FR, DE, ES & NL

Atlas of Experimental Toxicological Pathology Book Review:

Our aim in producing a colour atlas of toxicological guidelines itemize the investigations to be carried out pathology was to present a catalogue of histopathologi during the course of the study and they normally include: cal lesions which we had encountered over the years in clinical observations and behaviour; food intake and body various laboratory animal species exposed to a vast weight measurements; serum biochemistry; haema range of pharmaceuticals, agrochemicals and industrial tology; ECG and ophthalmology. At the end of a study, chemicals. While we believe a colour atlas is the ideal full macroscopic and microscopic examinations of the way to share our experiences with others, it quickly organ weight analyses together with tissues are essen became clear to us that for the atlas to be meaningful tial. By far the greater part of the material used in this the associated text must be comprehensive and contain book is from toxicity studies conducted in recent years ample literature references. and performed in compliance with the Good Laboratory The atlas is intended for both the trainee and the Practice standards of governmental regulatory bodies in experienced toxicological pathologist working with lab Europe, Japan and North America. oratory animals in the pharmaceutical, agrochemical or Toxicity studies are commonly carried out in rats, chemical environment.

Haschek and Rousseaux s Handbook of Toxicologic Pathology

Haschek and Rousseaux s Handbook of Toxicologic Pathology
Author: Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig
Publsiher: Academic Press
Total Pages: 3054
Release: 2013-05-01
ISBN 10: 0124157653
ISBN 13: 9780124157651
Language: EN, FR, DE, ES & NL

Haschek and Rousseaux s Handbook of Toxicologic Pathology Book Review:

Haschek and Rousseaux's Handbook 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. The 3e has been expanded by a full volume, and covers aspects of safety assessment not discussed in the 2e. Completely revised with many new chapters, it remains the most authoritative reference on toxicologic pathology for scientists and researchers studying and making decisions on drugs, biologics, medical devices and other chemicals, including agrochemicals and environmental contaminants. New topics include safety assessment, the drug life cycle, risk assessment, communication and management, carcinogenicity assessment, pharmacology and pharmacokinetics, biomarkers in toxicologic pathology, quality assurance, peer review, agrochemicals, nanotechnology, food and toxicologic pathology, the environment and toxicologic pathology and more. Provides new chapters and in-depth discussion of timely topics in the area of toxicologic pathology and broadens the scope of the audience to include toxicologists and pathologists working in a variety of settings 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

The Illustrated Dictionary of Toxicologic Pathology and Safety Science

The Illustrated Dictionary of Toxicologic Pathology and Safety Science
Author: Pritam S. Sahota,Robert H. Spaet,Philip Bentley,Zbigniew Wojcinski
Publsiher: CRC Press
Total Pages: 672
Release: 2019-05-13
ISBN 10: 0429655622
ISBN 13: 9780429655623
Language: EN, FR, DE, ES & NL

The Illustrated Dictionary of Toxicologic Pathology and Safety Science Book Review:

The Illustrated Dictionary of Toxicologic Pathology and Safety Science provides descriptions of commonly used terms in toxicologic pathology with over 800 photomicrographs and illustrations to augment the written material. It also contains concise information, describing terms used in related areas such as anatomy, metabolism, drug development, and the allied fields of general toxicology. The definitions and descriptions were prepared and peer reviewed by editors and contributors who are known experts in toxicologic pathology, toxicology, and drug development.

Pathology for Toxicologists

Pathology for Toxicologists
Author: Elizabeth McInnes
Publsiher: John Wiley & Sons
Total Pages: 216
Release: 2017-03-16
ISBN 10: 1118755316
ISBN 13: 9781118755310
Language: EN, FR, DE, ES & NL

Pathology for Toxicologists Book Review:

Non-pathologists, such as toxicologists and study personnel, can find it difficult to understand the data they receive from pathologists. Toxicological pathologists write long, detailed and highly technical reports. Study personnel are under daily pressure to decide whether lesions described in pathology reports are treatment-related and thus important to the pharmaceutical company or whether the lesions are background changes and thus of little significance. Written by experienced toxicological pathologists, Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study Personnel serves to bridge the gap in the understanding of pathology data, enabling non-pathologists to more easily comprehend pathology reports, better integrate pathology data into final study reports and ask pathologists relevant questions about the test compound. This succinct, fully referenced, full colour book is suitable for toxicologists at all stages of their training or career who want to know more about the pathology encountered in laboratory animals used in safety studies. Key features include important chapters on spontaneous and target organ lesions in rats, mice, non-human primates, mini pigs, rabbits and beagle dogs as well as information on general pathology, macroscopic target organ lesions, ancillary pathology techniques, haematology, biochemistry and adversity. Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study Personnel includes: Colour diagrams explaining how lesions are caused by either external compounds or spontaneously The anatomic variations and background lesions of laboratory animals Advice on sampling tissues, necropsy, ancillary pathology techniques and recording data A chapter on the haematology and biochemistry of laboratory animals Full colour photographs of common macroscopic lesions encountered in laboratory animals A comprehensive glossary

OECD Guidelines for Testing of Chemicals

OECD Guidelines for Testing of Chemicals
Author: Organisation for Economic Co-operation and Development
Publsiher: Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
Total Pages: 329
Release: 1981
ISBN 10: 9789264122215
ISBN 13: 9264122214
Language: EN, FR, DE, ES & NL

OECD Guidelines for Testing of Chemicals Book Review:

Recent Advances in Zebrafish Researches

Recent Advances in Zebrafish Researches
Author: Yusuf Bozkurt
Publsiher: BoD – Books on Demand
Total Pages: 218
Release: 2018-05-30
ISBN 10: 1789231728
ISBN 13: 9781789231724
Language: EN, FR, DE, ES & NL

Recent Advances in Zebrafish Researches Book Review:

Model organisms have been used in various disciplines in order to understand different mechanisms underlying the problems. From this point of view, the zebrafish has become a favorite model organism in different scientific research fields in recent years because of its rapid embryonic development, transparency of its embryos, and its large number of offspring along with several other advantages. Recent Advances in Zebrafish Researches demonstrates the role and the function of zebrafish in different research fields and totally includes 11 chapters, which have been written by the expert researches in their fields. With this book, every researcher will better understand different mechanisms underlying the problems at different disciplines using zebrafish as model organism.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 918
Release: 2016-11-18
ISBN 10: 1119097401
ISBN 13: 9781119097402
Language: EN, FR, DE, ES & NL

Drug Safety Evaluation Book Review:

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

Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 100
Release: 2009-07-20
ISBN 10: 9780309142311
ISBN 13: 0309142318
Language: EN, FR, DE, ES & NL

Accelerating the Development of Biomarkers for Drug Safety Book Review:

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Infant Formula

Infant Formula
Author: Institute of Medicine,Food and Nutrition Board,Committee on the Evaluation of the Addition of Ingredients New to Infant Formula
Publsiher: National Academies Press
Total Pages: 220
Release: 2004-07-10
ISBN 10: 0309091500
ISBN 13: 9780309091503
Language: EN, FR, DE, ES & NL

Infant Formula Book Review:

Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.

Drug Discovery Toxicology

Drug Discovery Toxicology
Author: Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publsiher: John Wiley & Sons
Total Pages: 584
Release: 2016-03-22
ISBN 10: 1119053390
ISBN 13: 9781119053392
Language: EN, FR, DE, ES & NL

Drug Discovery Toxicology Book Review:

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

Principles of Safety Pharmacology

Principles of Safety Pharmacology
Author: Michael K. Pugsley,Michael J Curtis
Publsiher: Springer
Total Pages: 481
Release: 2015-06-19
ISBN 10: 366246943X
ISBN 13: 9783662469439
Language: EN, FR, DE, ES & NL

Principles of Safety Pharmacology Book Review:

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Biomarkers in Toxicology

Biomarkers in Toxicology
Author: Ramesh C. Gupta
Publsiher: Academic Press
Total Pages: 1246
Release: 2019-02-13
ISBN 10: 0128146567
ISBN 13: 9780128146569
Language: EN, FR, DE, ES & NL

Biomarkers in Toxicology Book Review:

Biomarkers in Toxicology, Second Edition, is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This revised and completely updated edition includes both vertebrate and non-vertebrate species models for toxicological testing and the development of biomarkers. Divided into several key sections, this reference volume contains new chapters devoted to topics in microplastics, neuroimmunotoxicity and nutraceuticals, along with a look at the latest cutting-edge technologies used to detect biomarkers. Each chapter contains several references to current literature and important resources for further reading. Given this comprehensive treatment, this book is an essential reference for anyone interested in biomarkers across the scientific and biomedical fields. Evaluates the expansive literature, providing one resource covering all aspects of toxicology biomarkers Includes completely revised chapters, along with additional chapters on the newest developments in the field Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation, and much more

Drug Safety Evaluation

Drug Safety Evaluation
Author: Jean-Charles Gautier
Publsiher: Humana Press
Total Pages: 431
Release: 2010-10-28
ISBN 10: 9781603271868
ISBN 13: 1603271864
Language: EN, FR, DE, ES & NL

Drug Safety Evaluation Book Review:

Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular BiologyTM series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.

Preclinical Development Handbook

Preclinical Development Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1080
Release: 2008-03-21
ISBN 10: 9780470249048
ISBN 13: 0470249048
Language: EN, FR, DE, ES & NL

Preclinical Development Handbook Book Review:

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.