Histopathology of Preclinical Toxicity Studies

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

Histopathology of Preclinical Toxicity Studies Book Excerpt:

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

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: 2019-04-26
ISBN: 0429658060
Category: Medical
Language: EN, FR, DE, ES & NL

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

There has been a growing interest in toxicologic pathology, especially as related to its impact on the safety assessment of pharmaceuticals and chemicals, and in drug development. Thus, there is a growing need for an Illustrated Dictionary of Toxicology Pathology and Safety Science (IDTP) that this dictionary aims to fill. The language of toxicologic pathology may be less familiar to a broad range of safety scientists, especially those involved in the safety evaluation of pharmaceuticals and chemicals. The IDTP format provides the brevity and clarity that the user is not likely to receive in a textbook, even if adequately indexed. With the inclusion of descriptions for terms used in toxicology, drug metabolism/pharmacokinetics, and regulatory science, the scope of the IDTP is considerably broadened and decidedly unique in its appeal to all safety scientists. With over 800 photos and illustrations to provide visual context,* an important aim of the IDTP is to present pathological changes as reference examples for terminology, nomenclature, and term descriptions for the entry entry-level as well as seasoned toxicologic pathologist. It will also aid students and non-pathology specialists such as study directors, senior toxicology report reviewers, scientific management of contract research organizations, regulatory agencies, and drug development companies to better understand the biological significance of tissue changes. The IDTP provides a single reference volume for these users to further their understanding and appreciation of biologically significant pathology findings. The IDTP consists of four major areas: 1. A-Z Dictionary of Pathology encompassing all organ systems, together with relevant non-pathology terms supported by references in "For Further Reading" sections. 2. Appendix 1: An Overviews of Drug Development, Nonclinical Safety & Toxicologic Pathology, and Important/Special Topics. 3. Appendix 2: Diagnostic Criteria of for Proliferative Proliferative Lesions in Rodents (Rat and Mouse) and Selected Non-Rodent Laboratory Species containing illustrations with detailed references and links to source material. 4) Appendix 3: Mini-Atlas of Organ System Anatomy and Histology to help re-acquaint the non-pathologist safety scientist with many normal anatomical structures. The editors and contributing scientists (board-certified veterinary pathologists, board-certified toxicologists, allied health safety scientists, health regulatory representatives) have experience from bench-level pathology and toxicology to managing global preclinical safety units in leading pharmaceutical companies. They have considerable experience mentoring pharmaceutical industry project team members, interacting with industry clinicians and representatives of decision-making bodies within the industry, as well as with global health authorities, such as the FDA and EMA. These activities convinced them of the necessity for and usefulness of the IDTP. As experts in their field, they have undertaken the hard work of writing and compiling the information, making the IDTP an exceptional, go-to reference. *Illustrations Editor: Gregory Argentieri

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: 0128036214
Category: Medical
Language: EN, FR, DE, ES & NL

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

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

Principles and Methods of Toxicology Fifth Edition

Principles and Methods of Toxicology  Fifth Edition
Author: A. Wallace Hayes
Publsiher: CRC Press
Total Pages: 2296
Release: 2007-09-25
ISBN: 9780849337789
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Methods of Toxicology Fifth Edition Book Excerpt:

Founded on the paradox that all things are poisons and the difference between poison and remedy is quantity, the determination of safe dosage forms the base and focus of modern toxicology. In order to make a sound determination there must be a working knowledge of the biologic mechanisms involved and of the methods employed to define these mechanisms. While the vastness of the field and the rapid accumulation of data may preclude the possibility of absorbing and retaining more than a fraction of the available information, a solid understanding of the underlying principles is essential. Extensively revised and updated with four new chapters and an expanded glossary, this fifth edition of the classic text, Principles and Methods of Toxicology provides comprehensive coverage in a manageable and accessible format. New topics include 'toxicopanomics', plant and animal poisons, information resources, and non-animal testing alternatives. Emphasizing the cornerstones of toxicology-people differ, dose matters, and things change, the book begins with a review of the history of toxicology and followed by an explanation of basic toxicological principles, agents that cause toxicity, target organ toxicity, and toxicological testing methods including many of the test protocols required to meet regulatory needs worldwide. The book examines each method or procedure from the standpoint of technique and interpretation of data and discusses problems and pitfalls that may be associated with each. The addition of several new authors allow for a broader and more diverse treatment of the ever-changing and expanding field of toxicology. Maintaining the high-quality information and organizational framework that made the previous editions so successful, Principles and Methods of Toxicology, Fifth Edition continues to be a valuable resource for the advanced practitioner as well as the new disciple of toxicology.

Toxicologic Pathology

Toxicologic Pathology
Author: Pritam S. Sahota,James A. Popp,Jerry F. Hardisty,Chirukandath Gopinath,Page Bouchard
Publsiher: CRC Press
Total Pages: 1224
Release: 2018-08-31
ISBN: 0429997450
Category: Medical
Language: EN, FR, DE, ES & NL

Toxicologic Pathology Book Excerpt:

Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

Adverse Effects of Engineered Nanomaterials

Adverse Effects of Engineered Nanomaterials
Author: Bengt Fadeel,Antonio Pietroiusti,Anna A. Shvedova
Publsiher: Academic Press
Total Pages: 347
Release: 2012
ISBN: 0123869404
Category: Medical
Language: EN, FR, DE, ES & NL

Adverse Effects of Engineered Nanomaterials Book Excerpt:

An essential reference that discusses occupational exposure and the adverse health effects of engineered nanomaterials and highlights current and future biomedical applications of these nanomaterials in relation to nanosafety. Multi-authored book written by leading US and European experts on nanotoxicology and nanomedicine Discusses the health implications and a clinical translation of experimental data in this area Takes a schematic, non-exhaustive approach to summarize the most important research data in this field Includes a glossary, with a brief explanation of the term and with a reference to where the term or phrase has been used will be included within the book

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: 2016-03-16
ISBN: 1119053323
Category: Medical
Language: EN, FR, DE, ES & NL

Drug Discovery Toxicology Book Excerpt:

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

Pathology for Toxicologists

Pathology for Toxicologists
Author: Elizabeth McInnes
Publsiher: John Wiley & Sons
Total Pages: 216
Release: 2017-05
ISBN: 1118755405
Category: Science
Language: EN, FR, DE, ES & NL

Pathology for Toxicologists Book Excerpt:

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

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
Author: Alberto Lodola,Jeanne Stadler
Publsiher: John Wiley & Sons
Total Pages: 280
Release: 2011-03-31
ISBN: 0470922729
Category: Medical
Language: EN, FR, DE, ES & NL

Pharmaceutical Toxicology in Practice Book Excerpt:

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Rat Histopathology

Rat Histopathology
Author: P. Greaves,J. M. Faccini
Publsiher: Elsevier Science Limited
Total Pages: 302
Release: 1992
ISBN: 1928374650XXX
Category: Medical
Language: EN, FR, DE, ES & NL

Rat Histopathology Book Excerpt:

Hardbound. The need to update advances in histopathology that relate to toxicologic pathology has resulted in the stimulus to produce this second edition of Rat Histopathology. Consequently, each chapter has been expanded and updated, with more information on defining common and uncommon lesions, as well as on common strains of rat.This second edition follows the philosophy of the first and reflects the interests of the authors in human pathology, a useful inclusion because of the increasing evidence over recent years that many pathological processes in the rodent are quite similar to those occurring in man.This book will be of great value to toxicologists and pathologists as well as to medical and pharmaceutical libraries.

Comprehensive Toxicology Toxicology of the immune system

Comprehensive Toxicology  Toxicology of the immune system
Author: I. Glenn Sipes
Publsiher: Unknown
Total Pages: 534
Release: 1997
ISBN: 1928374650XXX
Category: Toxicology
Language: EN, FR, DE, ES & NL

Comprehensive Toxicology Toxicology of the immune system Book Excerpt:

Pathobiology of the Aging Mouse Nervous system special senses eye and ear digestive system integumentary system and mammary gland and musculoskeletal system

Pathobiology of the Aging Mouse  Nervous system  special senses  eye and ear   digestive system  integumentary system and mammary gland  and musculoskeletal system
Author: Ulrich Mohr
Publsiher: International Life Sciences Inst
Total Pages: 505
Release: 1996
ISBN: 1928374650XXX
Category: Science
Language: EN, FR, DE, ES & NL

Pathobiology of the Aging Mouse Nervous system special senses eye and ear digestive system integumentary system and mammary gland and musculoskeletal system Book Excerpt:

Standardized System of Nomenclature and Diagnostic Criteria

Standardized System of Nomenclature and Diagnostic Criteria
Author: Society of Toxicologic Pathologists
Publsiher: Unknown
Total Pages: 135
Release: 1990
ISBN: 1928374650XXX
Category: Laboratory animals
Language: EN, FR, DE, ES & NL

Standardized System of Nomenclature and Diagnostic Criteria Book Excerpt:

Current Catalog

Current Catalog
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1991
ISBN: 1928374650XXX
Category: Medicine
Language: EN, FR, DE, ES & NL

Current Catalog Book Excerpt:

First multi-year cumulation covers six years: 1965-70.

Alternatives to Laboratory Animals

Alternatives to Laboratory Animals
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2000
ISBN: 1928374650XXX
Category: Biological models
Language: EN, FR, DE, ES & NL

Alternatives to Laboratory Animals Book Excerpt:

International Classification of Rodent Tumours Digestive system

International Classification of Rodent Tumours  Digestive system
Author: Ulrich Mohr
Publsiher: Unknown
Total Pages: 135
Release: 1992
ISBN: 1928374650XXX
Category: Carcinogenicity testing
Language: EN, FR, DE, ES & NL

International Classification of Rodent Tumours Digestive system Book Excerpt:

Technical Report Series

Technical Report Series
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1998
ISBN: 1928374650XXX
Category: Cancer
Language: EN, FR, DE, ES & NL

Technical Report Series Book Excerpt:

Laboratory Animal Science

Laboratory Animal Science
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1994
ISBN: 1928374650XXX
Category: Laboratory animals
Language: EN, FR, DE, ES & NL

Laboratory Animal Science Book Excerpt:

General and Applied Toxicology

General and Applied Toxicology
Author: Bryan Ballantyne,Timothy C. Marrs,Tore L. M. Syversen
Publsiher: Unknown
Total Pages: 3755
Release: 2009
ISBN: 1928374650XXX
Category: Toxicology
Language: EN, FR, DE, ES & NL

General and Applied Toxicology Book Excerpt:

Veterinary and Human Toxicology

Veterinary and Human Toxicology
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2001
ISBN: 1928374650XXX
Category: Toxicology
Language: EN, FR, DE, ES & NL

Veterinary and Human Toxicology Book Excerpt: