Histopathology of Preclinical Toxicity Studies Book
Score: 4.5
From 2 Ratings

Histopathology of Preclinical Toxicity Studies


  • Author : Peter Greaves
  • Publisher : Elsevier
  • Release Date : 2007-03-23
  • Genre: Medical
  • Pages : 960
  • ISBN 10 : 0080471307

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Histopathology of Preclinical Toxicity Studies 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

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book

A Comprehensive Guide to Toxicology in Nonclinical Drug Development


  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2016-11-03
  • Genre: Medical
  • Pages : 986
  • ISBN 10 : 9780128036211

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development 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

The Illustrated Dictionary of Toxicologic Pathology and Safety Science Book

The Illustrated Dictionary of Toxicologic Pathology and Safety Science


  • Author : Pritam S. Sahota
  • Publisher : CRC Press
  • Release Date : 2019-05-13
  • Genre: Medical
  • Pages : 672
  • ISBN 10 : 9780429655623

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The Illustrated Dictionary of Toxicologic Pathology and Safety Science Excerpt :

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.

The Illustrated Dictionary of Toxicologic Pathology and Safety Science Book

The Illustrated Dictionary of Toxicologic Pathology and Safety Science


  • Author : Pritam S. Sahota
  • Publisher : CRC Press
  • Release Date : 2019-04-26
  • Genre: Medical
  • Pages : 672
  • ISBN 10 : 9780429658068

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The Illustrated Dictionary of Toxicologic Pathology and Safety Science 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 Lesi

Current Topics in Nonclinical Drug Development Book

Current Topics in Nonclinical Drug Development


  • Author : Pritam S. Sahota
  • Publisher : CRC Press
  • Release Date : 2020-12-23
  • Genre: Medical
  • Pages : 318
  • ISBN 10 : 9780429648496

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Current Topics in Nonclinical Drug Development Excerpt :

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book

A Comprehensive Guide to Toxicology in Preclinical Drug Development


  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2012-11-16
  • Genre: Medical
  • Pages : 885
  • ISBN 10 : 9780123878151

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A Comprehensive Guide to Toxicology in Preclinical Drug Development Excerpt :

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

Pathology for Toxicologists Book

Pathology for Toxicologists


  • Author : Elizabeth McInnes
  • Publisher : John Wiley & Sons
  • Release Date : 2017-03-16
  • Genre: Science
  • Pages : 216
  • ISBN 10 : 9781118755310

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Pathology for Toxicologists 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

Toxicologic Pathology Book

Toxicologic Pathology


  • Author : Pritam S. Sahota
  • Publisher : CRC Press
  • Release Date : 2018-08-31
  • Genre: Medical
  • Pages : 1224
  • ISBN 10 : 9780429997457

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Toxicologic Pathology 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.

Regulatory Toxicology Book

Regulatory Toxicology


  • Author : Franz-Xaver Reichl
  • Publisher : Springer
  • Release Date : 2014-03-27
  • Genre: Medical
  • Pages : 946
  • ISBN 10 : 3642353738

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Regulatory Toxicology Excerpt :

This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.

Principles and Methods of Toxicology  Fifth Edition Book
Score: 3.5
From 2 Ratings

Principles and Methods of Toxicology Fifth Edition


  • Author : A. Wallace Hayes
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Genre: Medical
  • Pages : 2304
  • ISBN 10 : 084933778X

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Principles and Methods of Toxicology Fifth Edition 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.

Drug Safety Evaluation Book

Drug Safety Evaluation


  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release Date : 2016-11-18
  • Genre: Medical
  • Pages : 918
  • ISBN 10 : 9781119097402

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Drug Safety Evaluation Excerpt :

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

Drug Safety Evaluation Book

Drug Safety Evaluation


  • Author : Jean-Charles Gautier
  • Publisher : Humana Press
  • Release Date : 2010-10-28
  • Genre: Medical
  • Pages : 431
  • ISBN 10 : 1603271864

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Drug Safety Evaluation Excerpt :

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.

Principles of Safety Pharmacology Book

Principles of Safety Pharmacology


  • Author : Michael K. Pugsley
  • Publisher : Springer
  • Release Date : 2015-06-19
  • Genre: Medical
  • Pages : 481
  • ISBN 10 : 9783662469439

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Principles of Safety Pharmacology Excerpt :

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.

Ocular Toxicology Book

Ocular Toxicology


  • Author : Keith Green
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • Genre: Medical
  • Pages : 378
  • ISBN 10 : 9781461518877

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Ocular Toxicology Excerpt :

On behalf of the editorial board and the organizing committee of the 4th congress of the International Society of Ocular Toxicology (I SOT), held in AnnecyNeyrier du Lac, France, October 9 -13, 1994, we are pleased to present to the ocular toxicology community this indexed volume of our congress proceedings. The 4th congress was designed primarily to facilitate and update the knowledge in ocular electrophysiology and ocular pharmacokinetics, in both the clinical and preclinical aspects. The outcome of this 4th congress, established in this volume, is a useful contribution to the meth odology in both fields and will hopefully assist in the evaluation and interpretation of ocular findings recorded in animal studies on drugs and other chemicals, in order to protect human health. Undoubtedly, work on the mechanisms of ocular toxicology in the process of pharmaceutical development must continue and these proceedings, embodying the presented papers, will add to the data base. The editors, the congress organizing committee and the members of the International Society of Ocular Toxicology thank the speakers who gave their time, knowledge, and expertise to assist us in this project. The following manuscripts contain the main substance of each of the platform presentations and, in some cases, much more. Moreover, our thanks go to all the participants coming from a range of background- regulatory, academic and industrial -for their attention and excellent contributions during the discussion.

Public Health Consequences of E Cigarettes Book

Public Health Consequences of E Cigarettes


  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release Date : 2018-05-18
  • Genre: Medical
  • Pages : 774
  • ISBN 10 : 9780309468374

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Public Health Consequences of E Cigarettes Excerpt :

Millions of Americans use e-cigarettes. Despite their popularity, little is known about their health effects. Some suggest that e-cigarettes likely confer lower risk compared to combustible tobacco cigarettes, because they do not expose users to toxicants produced through combustion. Proponents of e-cigarette use also tout the potential benefits of e-cigarettes as devices that could help combustible tobacco cigarette smokers to quit and thereby reduce tobacco-related health risks. Others are concerned about the exposure to potentially toxic substances contained in e-cigarette emissions, especially in individuals who have never used tobacco products such as youth and young adults. Given their relatively recent introduction, there has been little time for a scientific body of evidence to develop on the health effects of e-cigarettes. Public Health Consequences of E-Cigarettes reviews and critically assesses the state of the emerging evidence about e-cigarettes and health. This report makes recommendations for the improvement of this research and highlights gaps that are a priority for future research.