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| Author | : Peter Greaves |
| Publisher | : Elsevier |
| Total Pages | : 962 |
| Release | : 2007-03-23 |
| Genre | : Science |
| ISBN | : 0080471307 |
Download Histopathology of Preclinical Toxicity Studies Book in PDF, ePub and Kindle
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
| Author | : Peter Greaves |
| Publisher | : Elsevier Publishing Company |
| Total Pages | : 844 |
| Release | : 1990 |
| Genre | : Medical |
| ISBN | : |
Download Histopathology of Preclinical Toxicity Studies Book in PDF, ePub and Kindle
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.
| Author | : Ali S. Faqi |
| Publisher | : Academic Press |
| Total Pages | : 903 |
| Release | : 2012-10-18 |
| Genre | : Medical |
| ISBN | : 0123878160 |
Download A Comprehensive Guide to Toxicology in Preclinical Drug Development Book in PDF, ePub and Kindle
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
| Author | : Elizabeth Fiona McInnes |
| Publisher | : Elsevier Health Sciences |
| Total Pages | : 256 |
| Release | : 2011-10-24 |
| Genre | : Medical |
| ISBN | : 0702049247 |
Download Background Lesions in Laboratory Animals E-Book Book in PDF, ePub and Kindle
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
| Author | : Pritam S. Sahota |
| Publisher | : CRC Press |
| Total Pages | : 1019 |
| Release | : 2013-04-09 |
| Genre | : Medical |
| ISBN | : 1439872104 |
Download Toxicologic Pathology Book in PDF, ePub and Kindle
As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Safety Assessment presents a histopathologic description of lesions observed during drug development and discusses their implication in the drug development process. Divided into two sections, the book systematically assists pathologists in making a determination as to the origin and potential importance of a lesion and its relevance for assessing human risk. The first section includes eight "concept" chapters to orient pathologists in areas that are important for effective interaction with other pathologists as well as the many non-pathologists involved in drug development. The second section is made up of organ-based chapters, each including light microscopic and electron microscopic descriptions of pathological lesions, differential diagnoses, biological consequences, pathogenesis, mechanism of lesion formation, and the expected clinical pathology correlates. This volume presents critical information—both published and unpublished and gained through personal experience—to improve the quality of drug safety evaluation and to expedite and improve the efficiency of the process. This book is crafted to assist students, residents, and toxicologic pathologists in their early career phase by serving as a resource that can effectively be used as a ready reference next to the microscope. In addition, more experienced pathologists will find this volume to be invaluable during their assessments. The book is also a valuable reference for toxicologists to assist in understanding compound-related pathological findings and to provide background for working on a range of toxicological problems.
| Author | : Wanda M. Haschek-Hock |
| Publisher | : Academic Press |
| Total Pages | : 694 |
| Release | : 2023-02-18 |
| Genre | : Medical |
| ISBN | : 0323910521 |
Download Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 Book in PDF, ePub and Kindle
Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to five separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety. Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity Chapters dealing with product-specific practices address pathology and regulatory issues Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts
| Author | : Ali S. Faqi |
| Publisher | : Elsevier |
| Total Pages | : 1074 |
| Release | : 2024-02-11 |
| Genre | : Medical |
| ISBN | : 0323984622 |
Download A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book in PDF, ePub and Kindle
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes 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 expectations associated with working in nonclinical toxicology
| Author | : Pritam S. Sahota |
| Publisher | : CRC Press |
| Total Pages | : 1897 |
| Release | : 2018-08-14 |
| Genre | : Medical |
| ISBN | : 0429997450 |
Download Toxicologic Pathology Book in PDF, ePub and Kindle
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.
| Author | : Elizabeth McInnes |
| Publisher | : John Wiley & Sons |
| Total Pages | : 216 |
| Release | : 2017-03-24 |
| Genre | : Science |
| ISBN | : 1118755308 |
Download Pathology for Toxicologists Book in PDF, ePub and Kindle
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
| Author | : Shayne Cox Gad |
| Publisher | : John Wiley & Sons |
| Total Pages | : 918 |
| Release | : 2016-11-18 |
| Genre | : Medical |
| ISBN | : 1119097401 |
Download Drug Safety Evaluation Book in PDF, ePub and Kindle
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
