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Author: Peter Greaves
Publisher: Elsevier
ISBN: 0080471307
Category : Science
Languages : en
Pages : 962
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Book Description
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
ISBN: 0080471307
Category : Science
Languages : en
Pages : 962
Get Book Here
Book Description
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
ISBN:
Category : Medical
Languages : en
Pages : 844
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Book Description
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: Elizabeth Fiona McInnes
Publisher: Elsevier Health Sciences
ISBN: 0702049247
Category : Medical
Languages : en
Pages : 141
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Book Description
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: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878160
Category : Medical
Languages : en
Pages : 903
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Book Description
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: Pritam S. Sahota
Publisher: CRC Press
ISBN: 1439872120
Category : Medical
Languages : en
Pages : 987
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Book Description
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 Saf
Author: Michael K. Pugsley
Publisher: Springer
ISBN: 366246943X
Category : Medical
Languages : en
Pages : 477
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Book Description
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.
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0128036214
Category : Medical
Languages : en
Pages : 988
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Book Description
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
Author: Pritam S. Sahota
Publisher: CRC Press
ISBN: 0429658060
Category : Medical
Languages : en
Pages : 691
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Book Description
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
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097401
Category : Medical
Languages : en
Pages : 918
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Book Description
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author: Adrian Kilcoyne
Publisher: OUP Oxford
ISBN: 0191510394
Category : Medical
Languages : en
Pages : 473
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Book Description
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
